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Monday, May 21, 2012

NIPER NOTES : NEW FDA approved drugs 2012-

NEW FDA approved drugs 2012-


Dermatology/Plastic SurgeryErivedge (vismodegib); Genentech; For the treatment of basal cell carcinoma, Approved 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


EndocrinologyBio-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 II diabetes, Approved February 2012


Korlym (mifepristone); Corcept Therapeutics; For the control of hyperglycemia in adults with endogenous Cushing’s 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


GastroenterologyElelyso (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


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


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/UrologyAfinitor (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


NeurologyNeupro (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/GynecologyNatazia (estradiol valerate and estradiol valerate/dienogest); Bayer HealthCare; For the treatment of heavy menstrual bleeding, Approved March 2012


OncologyAfinitor (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 breakthrough cancer pain, Approved January of 2012


Votrient (pazopanib); GlaxoSmithKline; For the treatment of soft tissue sarcoma, Approved April 2012


OphthalmologyZioptan (tafluprost ophthalmic solution); Merck; For the treatment of elevated intraocular pressure, Approved February 2012


OtolaryngologyDymista (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/NeonatologyQnasl (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/ToxicologyVoraxaze (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


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


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

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