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BET n GATE ConsultancyBET n GATE ConsultancyComplete solution for Pharma EntranceComplete solution for Pharma Entrance

SINCE 2005SINCE 2005

FDA APPROVED DRUG LIST 2011 TO JUNE 2012

2012

Dermatology/Plastic Surgery Erivedge (vismodegib) ; Genentech; For the treatment of basal cell carcinoma, Approve d January

2012

Picato (ingenol mebutate) gel ; LEO Pharma; For the treatment of actinic keratosis, Approved

January 2012

Sklice (ivermectin) lotion ; Sanofi Pasteur; For the treatment of head lice, Approved February 2012

Endocrinology Bio-T-Gel (testosterone gel) ; Teva Pharmaceuticals; For the treatment of hypogonadism, Approved

February 2012

Elelyso (taliglucerase alfa) ; Pfizer Inc; For the treatment of Gaucher disease, Approved May 2012

Jentadueto (linagliptin plus metformin hydrochloride) ; Eli Lilly; For the treatment of type IIdiabetes, Approved February 2012

Korlym (mifepristone) ; Corcept Therapeutics; For the control of hyperglycemia in adults with

endogenous Cushings syndrome, Approved February 2012

Ultresa (pancrelipase) delayed-release capsules ; Aptalis Pharma; For the treatment of exocrine

pancreatic insufficiency due to cystic fibrosis or other conditions, Approved March 2012

Viokace (pancrelipase) tablets ; Aptalis Pharma; For the treatment of exocrine pancreatic

insufficiency due to chronic pancreatitis or pancreatectomy, Approved March 2012

Gastroenterology Elelyso (taliglucerase alfa) ; Pfizer Inc; For the treatment of Gaucher disease, Approved May 2012

Ultresa (pancrelipase) delayed-release capsules ; Aptalis Pharma; For the treatment of exocrine

pancreatic insufficiency due to cystic fibrosis or other conditions, Approved March 2012

Viokace (pancrelipase) tablets ; Aptalis Pharma; For the treatment of exocrine pancreatic

insufficiency due to chronic pancreatitis or pancreatectomy, Approved March 2012

Hematology Elelyso (taliglucerase alfa) ; Pfizer Inc; For the treatment of Gaucher disease, Approved May 2012

Contact:- 9909131388, 9913767101, 9426023054 www.betngateconsultancy.com 1

http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1183http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1181http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1187http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1187http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1190http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1203http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1186http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1188http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1188http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1191http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1192http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1203http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1191http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1192http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1203http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1183http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1181http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1187http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1190http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1203http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1186http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1188http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1191http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1192http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1203http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1191http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1192http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1203

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Omontys (peginesatide) ; Affymax; For the treatment of anemia due to chronic kidney disease,

Approved March 2012

Immunology/Infectious DiseasesQnasl (beclomethasone dipropionate) nasal aerosol ; Teva Pharmaceuticals; For the treatment of

seasonal and perennial allergic rhinitis, Approved March 2012

MusculoskeletalElelyso (taliglucerase alfa) ; Pfizer Inc; For the treatment of Gaucher disease, Approved May 2012

Neupro (Rotigotine Transdermal System) ; UCB; For the treatment of Restless Legs Syndrome,

Approved April 2012

Stendra (avanafil) ; Vivus; For the treatment of erectile dysfunction, Approved April 2012

Votrient (pazopanib) ; GlaxoSmithKline; For the treatment of soft tissue sarcoma, Approved April

2012

Nephrology/Urology Afinitor (everolimus) ; Novartis Pharmaceuticals Corporation; For the treatment of renal

angiomyolipoma associated with tuberous sclerosis complex, Approved April 2012

Inlyta (axitinib) ; Pfizer; For the treatment of advanced renal cell carcinoma, Approved January 2012

Omontys (peginesatide) ; Affymax; For the treatment of anemia due to chronic kidney disease,

Approved March 2012

Stendra (avanafil) ; Vivus; For the treatment of erectile dysfunction, Approved April 2012

Voraxaze (glucarpidase) ; BTG International; For the treatment of toxic plasma methotrexate

concentrations in patients with impaired renal function, Approved January 2012

Neurology Neupro (Rotigotine Transdermal System) ; UCB; For the treatment of Restless Legs Syndrome,

Approved April 2012

Subsys (fentanyl sublingual spray) ; Insys Therapeutics; For the treatment of breakthrough cancer

pain, Approved January of 2012

Obstetrics/Gynecology Natazia (estradiol valerate and estradiol valerate/dienogest) ; Bayer HealthCare; For the

treatment of heavy menstrual bleeding, Approved March 2012

Oncology Contact:- 9909131388, 9913767101, 9426023054 www.betngateconsultancy.com 2

http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1197http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1197http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1196http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1203http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1198http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1202http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1202http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1200http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1199http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1182http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1197http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1197http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1202http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1202http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1180http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1198http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1179http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1195http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1197http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1196http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1203http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1198http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1202http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1200http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1199http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1182http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1197http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1202http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1180http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1198http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1179http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1195

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Afinitor (everolimus) ; Novartis Pharmaceuticals Corporation; For the treatment of renal

angiomyolipoma associated with tuberous sclerosis complex, Approved April 2012

Erivedge (vismodegib) ; Genentech; For the treatment of basal cell carcinoma, Approved January

2012

Inlyta (axitinib) ; Pfizer; For the treatment of advanced renal cell carcinoma, Approved January 2012

Picato (ingenol mebutate) gel ; LEO Pharma; For the treatment of actinic keratosis, Approved

January 2012

Subsys (fentanyl sublingual spray) ; Insys Therapeutics; For the treatment of breakth rough cancer

pain, Approved January of 2012

Votrient (pazopanib) ; GlaxoSmithKline; For the treatment of soft tissue sarcoma, Approved April

2012

Ophthalmology Zioptan (tafluprost ophthalmic solution) ; Merck; For the treatment of elevated intraocular

pressure, Approved February 2012

Otolaryngology Dymista (azelastine hydrochloride and fluticasone propionate) ; Meda Pharmaceuticals Inc.; For

the relief of symptoms of seasonal allergic rhinitis, Approved May 2012

Qnasl (beclomethasone dipropionate) nasal aerosol ; Teva Pharmaceuticals; For the treatment of

seasonal and perennial allergic rhinitis, Approved March 2012

Pediatrics/Neonatology Qnasl (beclomethasone dipropionate) nasal aerosol ; Teva Pharmaceuticals; For the treatment of

seasonal and perennial allergic rhinitis, Approved March 2012

Sklice (ivermectin) lotion ; Sanofi Pasteur; For the treatment of head lice, Approved February 2012

Surfaxin (lucinactant) ; Discovery Laboratories; For the treatment of respiratory distress syndrome in

premature infants, Approved March 2012

Pharmacology/Toxicology Voraxaze (glucarpidase) ; BTG International; For the treatment of toxic plasma methotrexate

concentrations in patients with impaired renal function, Approved January 2012

Pulmonary/Respiratory DiseasesDymista (azelastine hydrochloride and fluticasone propionate) ; Meda Pharmaceuticals Inc.; For

the relief of symptoms of seasonal allergic rhinitis, Approved May 2012

Contact:- 9909131388, 9913767101, 9426023054 www.betngateconsultancy.com 3

http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1199http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1183http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1182http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1181http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1179http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1200http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1189http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1204http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1196http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1196http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1187http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1187http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1193http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1180http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1204http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1199http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1183http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1182http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1181http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1179http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1200http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1189http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1204http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1196http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1196http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1187http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1193http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1180http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1204

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Kalydeco (ivacaftor) ; Vertex Pharmaceuticals; For the treatment of cystic fibrosis with the G551D

mutation in the CFTR gene, Approved January of 2012

Qnasl (beclomethasone dipropionate) nasal aerosol ; Teva Pharmaceuticals; For the treatment of

seasonal and perennial allergic rhinitis, Approved March 2012

Surfaxin (lucinactant) ; Discovery Laboratories; For the treatment of respiratory distress syndrome in

premature infants, Approved March 2012

Rheumatology Stendra (avanafil) ; Vivus; For the treatment of erectile dysfunction, Approved April 20 12

2011

2011

Cardiology/Vascular DiseasesBrilinta (ticagrelor) ; AstraZeneca; For the reduction of thrombotic events in patients with acute coronary syndrome,

Approved July 2011

Edarbi (azilsartan medoxomil) ; Takeda; For the treatment of hypertension, Approved February 2011

Edarbyclor (azilsartan medoxomil and chlorthalidone) ; Takeda Pharmaceutical; For the treatment of hypertension,

Approved December of 2011

Xarelto (rivaroxaban) ; Janssen Pharmaceuticals; For the reduction in the risk of stroke and systemic embolism resulting

from atrial fibrillation, Approved November 2011

Xarelto (rivaroxaban) ; Bayer; For the prophylaxis of deep vein thrombosis during knee or hip replacement surgery,

Approved July 2011

Dermatology/Plastic Surgery Firazyr (icatibant) ; Shire; For the treatment of acute attacks of hereditary angioedema, Approved August of 2011

Gralise (gabapentin) ; Abbott; For the treatment of postherpetic neuralgia, Approved February 2011

laViv (azficel-T) ; Fibrocell Science; For the improvement of nasolabial fold wrinkles in adults, Approved June 2011

Sylatron (peginterferon alfa-2b) ; Merck; For the treatment of melanoma, Approved April 2011

Yervoy (ipilimumab) ; Bristol-Myers Squibb; For the treatment of metastatic melanoma, Approved March 2011

Zelboraf (vemurafenib) ; Roche; For the treatment of BRAF + melanoma, Approved August of 2011

Endocrinology Contact:- 9909131388, 9913767101, 9426023054 www.betngateconsultancy.com 4

http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1184http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1196http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1193http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1202http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1202http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1158http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1158http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1136http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1178http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1175http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1161http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1164http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1134http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1153http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1153http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1140http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1139http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1166http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1166http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1184http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1196http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1193http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1202http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1158http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1136http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1178http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1175http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1161http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1164http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1134http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1153http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1140http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1139http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1166

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Afinitor (everolimus) ; Novartis; For the treatment of advanced pancreatic neuroendocrine tumors, Approved May 2011

Juvisync (sitagliptin and simvastatin) ; Merck; For the treatment of type II diabetes, Approved October 2011

Sutent (sunitinib malate) ; Pfizer; For the treatment of pancreatic neuroendocrine tumors, Approved May 2011

Tradjenta (linagliptin) ; Boehringer Ingelheim; For the treatment of type II diabetes, Approved May 2011

Gastroenterology Afinitor (everolimus) ; Novartis; For the treatment of advanced pancreatic neuroendocrine tumors, Approved Ma y 2011

Dificid (fidaxomicin) ; Optimer Pharmaceuticals; For the treatment of Clostridium difficile-associated diarrhea, Approved

May 2011

Duexis (ibuprofen and famotidine) ; Horizon Pharma; For the relief of rheumatoid arthritis and osteoarthritis and

prevention of gastric ulcers, Approved April 2011

Incivek (telaprevir) ; Vertex; For the treatment of genotype 1 chronic hepatitis C, Approved May 2011

Rectiv (nitroglycerin) ointment 0.4% ; ProStrakan; For the treatment of chronic anal fissure, Approved June 2011

Sutent (sunitinib malate) ; Pfizer; For the treatment of pancreatic neuroendocrine tumors, Approved May 2011

Victrelis (boceprevir) ; Merck; For the treatment of chronic hepatitis C genotype 1, Approved May 2011

Hematology Adcretris (brentuximab vedotin) ; Seattle Genetics; For the treatment of Hodgkin lymphoma and anaplastic large cell

lymphoma, Approved August 2011

Erwinaze (asparaginase Erwinia chrysanthemi) ; Eusa Pharma; For the treatment of acute lymphoblastic leukemia,

Approved November of 2011

Ferriprox (deferiprone) ; Apotex; For the treatment of transfusional iron overload due to thalassemia, Approved October

2011

Jakafi (ruxolitinib) ; Incyte; For the treatment of myelofibrosis, Approved November 2011

Soliris (eculizumab) ; Alexion; For the treatment of atypical hemolytic uremic syndrome, Approved September 2011

Xarelto (rivaroxaban) ; Bayer; For the prophylaxis of deep vein thrombosis during knee or hip replacement surgery,

Approved July 2011

Immunology/Infectious DiseasesArcapta (indacaterol maleate inhalation powder) ; Novartis; For the treatment of airflow obstruction resulting from chronic

obstructive pulmonary disease, Approved July 2011

Benlysta (belimumab) ; Human Genome Sciences; For the treatment of systemic lupus erythematosus, Approved March

2011

Contact:- 9909131388, 9913767101, 9426023054 www.betngateconsultancy.com 5

http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1145http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1168http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1147http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1148http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1148http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1145http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1152http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1143http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1150http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1150http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1160http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1160http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1147http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1149http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1149http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1162http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1162http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1171http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1171http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1169http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1169http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1174http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1174http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1167http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1161http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1157http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1157http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1138http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1138http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1145http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1168http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1147http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1148http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1145http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1152http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1143http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1150http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1160http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1147http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1149http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1162http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1171http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1169http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1174http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1167http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1161http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1157http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1138

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Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) ; Gilead; For the treatment of HIV-1 in treatment-naive

adults, Approved August of 2011

Daliresp (roflumilast) ; Forest Pharmaceuticals; For the treatment of chronic obstructive pulmonary disease, Approved

February 2011

Dificid (fidaxomicin) ; Optimer Pharmaceuticals; For the treatment of Clostridium difficile-associated diarrhea, Approved

May 2011

Edurant (rilpivirine) ; Tibotec; For the treatment of HIV-1, Approved May 2011

Firazyr (icatibant) ; Shire; For the treatment of acute attacks of hereditary angioedema, Approved August of 2011

Gralise (gabapentin) ; Abbott; For the treatment of postherpetic neuralgia, Approved February 2011

Incivek (telaprevir) ; Vertex; For the treatment of genotype 1 chronic hepatitis C, Approved May 2011

Nulojix (belatacept) ; Bristol-Myers Squibb; For the prevention of organ rejection following kidney transplant, Approved

June 2011

Victrelis (boceprevir) ; Merck; For the treatment of chronic hepatitis C genotype 1, Approved May 2011

MusculoskeletalActemra (tocilizumab) ; Genentech; For the treatment of systemic juvenile idiopathic arthritis, Approved April 2011

Duexis (ibuprofen and famotidine) ; Horizon Pharma; For the relief of rheumatoid arthritis and osteoarthritis and

prevention of gastric ulcers, Approved April 2011

Nephrology/Urology Anturol (oxybutynin) Gel ; Antares Pharma; For the treatment of overactive bladder, Approved December 2011

Nulojix (belatacept) ; Bristol-Myers Squibb; For the prevention of organ rejection following kidney transplant, Approved

June 2011

Soliris (eculizumab) ; Alexion; For the treatment of atypical hemolytic uremic syndrome, Approved September 2011

Neurology Abstral (fentanyl sublingual tablets) ; ProStrakan; For the treatment of breakthrough cancer pain in opioid-tolerant

patients, Approved January 2011

Exparel (bupivacaine liposome injectable suspension) ; Pacira Pharmaceuticals; For postsurgical analgesia, Approved

November 2011

Gralise (gabapentin) ; Abbott; For the treatment of postherpetic neuralgia, Approved February 2011

Horizant (gabapentin enacarbil) ; GlaxoSmithKline; For the treatment of restless legs syndrome, Approved April 2011

Intermezzo (zolpidem tartrate sublingual tablet) ; Transcept Pharmaceuticals; For the treatment of insomnia, Approved

November 2011

Contact:- 9909131388, 9913767101, 9426023054 www.betngateconsultancy.com 6

http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1163http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1137http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1152http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1146http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1164http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1134http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1150http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1150http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1154http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1149http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1149http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1144http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1143http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1177http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1177http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1154http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1167http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1130http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1172http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1172http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1134http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1142http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1142http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1176http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1163http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1137http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1152http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1146http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1164http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1134http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1150http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1154http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1149http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1144http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1143http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1177http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1154http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1167http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1130http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1172http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1134http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1142http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1176

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Lazanda (fentanyl citrate) nasal spray ; Archimedes; For the management of breakthrough cancer pain, Approved June

2011

Onfi (clobazam) ; Lundbeck; For the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome, Approved

October 2011

Oxecta (oxycodone HCl) ; Pfizer; For the management of acute and chronic moderate to severe pain, Approved June 2011

Potiga (ezogabine) ; Valeant Pharmaceuticals; For the treatment of partial-onset seizures, Approved June 2011

Viibryd (vilazodone hydrochloride) ; Clinical Data; For the treatment of major depressive disorder, Approved Janu ary 2011

Obstetrics/Gynecology Makena (hydroxyprogesterone caproate injection) ; Hologic; For the prevention of risk of preterm birth, Approved

February 2011

Oncology Abstral (fentanyl sublingual tablets) ; ProStrakan; For the treatment of breakthrough cancer pain in opioid-tolerant

patients, Approved January 2011

Adcretris (brentuximab vedotin) ; Seattle Genetics; For the treatment of Hodgkin lymphoma and anaplastic large cell

lymphoma, Approved August 2011

Afinitor (everolimus) ; Novartis; For the treatment of advanced pancreatic neuroendocrine tumors, Approved May 2011

Erwinaze (asparaginase Erwinia chrysanthemi) ; Eusa Pharma; For the treatment of acute lymphoblastic leukemia,

Approved November of 2011

Lazanda (fentanyl citrate) nasal spray ; Archimedes; For the management of breakthrough cancer pain, Approved June

2011

Sutent (sunitinib malate) ; Pfizer; For the treatment of pancreatic neuroendocrine tumors, Approved May 2011

Sylatron (peginterferon alfa-2b) ; Merck; For the treatment of melanoma, Approved April 2011

Vandetanib (vandetanib) ; Astra Zeneca; For the treatment of thyroid cancer, Approved April 2011

Xalkori (crizotinib) ; Pfizer; For the treatment of ALK+ non-small cell lung cancer, Approved August of 2011

Yervoy (ipilimumab) ; Bristol-Myers Squibb; For the treatment of metastatic melanoma, Approved March 2011

Zelboraf (vemurafenib) ; Roche; For the treatment of BRAF + melanoma, Approved August of 2011

Zytiga (abiraterone acetate) ; Centocor Ortho Biotech; For the treatment of prostate cancer, Approved May 2011

Ophthalmology Eylea (aflibercept) ; Regeneron Pharmaceuticals; For the treatment of neovascular (wet) age-related macular degeneration,

Approved November 2011

Contact:- 9909131388, 9913767101, 9426023054 www.betngateconsultancy.com 7

http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1159http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1159http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1170http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1170http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1155http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1156http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1131http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1135http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1135http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1130http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1162http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1162http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1145http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1171http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1171http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1159http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1159http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1147http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1140http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1141http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1141http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1165http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1165http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1139http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1166http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1166http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1151http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1151http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1173http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1173http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1159http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1170http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1155http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1156http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1131http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1135http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1130http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1162http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1145http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1171http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1159http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1147http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1140http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1141http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1165http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1139http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1166http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1151http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1173

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Otolaryngology Vandetanib (vandetanib) ; Astra Zeneca; For the treatment of thyroid cancer, Approved April 2011

Pediatrics/Neonatology Actemra (tocilizumab) ; Genentech; For the treatment of systemic juvenile idiopathic arthritis, Approved April 2011

Daliresp (roflumilast) ; Forest Pharmaceuticals; For the treatment of chronic obstructive pulmonary disease, Approved

February 2011

Onfi (clobazam) ; Lundbeck; For the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome , Approved

October 2011

Pharmacology/Toxicology Oxecta (oxycodone HCl) ; Pfizer; For the management of acute and chronic moderate to severe pain, Approved June 2011

Psychiatry/Psychology Intermezzo (zolpidem tartrate sublingual tablet) ; Transcept Pharmaceuticals; For the treatment of insomnia, Approved

November 2011

Viibryd (vilazodone hydrochloride) ; Clinical Data; For the treatment of major depressive disorder, Approved January 2011

Pulmonary/Respiratory Diseases

Arcapta (indacaterol maleate inhalation powder) ; Novartis; For the treatment of airflow obstruction resulting from chronicobstructive pulmonary disease, Approved July 2011

Daliresp (roflumilast) ; Forest Pharmaceuticals; For the treatment of chronic obstructive pulmonary disease, Approved

February 2011

Xalkori (crizotinib) ; Pfizer; For the treatment of ALK+ non-small cell lung cancer, Approved August of 2011

Rheumatology

Actemra (tocilizumab) ; Genentech; For the treatment of systemic juvenile idiopathic arthritis, Approved April 2011

Duexis (ibuprofen and famotidine) ; Horizon Pharma; For the relief of rheumatoid arthritis and osteoarthritis and

prevention of gastric ulcers, Approved April 2011

Trauma/Emergency MedicineExparel (bupivacaine liposome injectable suspension) ; Pacira Pharmaceuticals; For postsurgical analgesia, Approved

November 2011

Contact:- 9909131388, 9913767101, 9426023054 www.betngateconsultancy.com 8

http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1141http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1141http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1144http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1137http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1170http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1170http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1155http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1176http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1131http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1157http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1157http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1137http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1165http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1165http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1144http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1143http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1172http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1172http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1141http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1144http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1137http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1170http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1155http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1176http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1131http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1157http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1137http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1165http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1144http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1143http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1172