FDA Approved Drugs in 2012
The following drugs were approved for sale in the United States.
Dermatology/Plastic Surgery
Erivedge (vismodegib); Genentech; For the treatment of basal cell carcinoma, Approved January 2012
Horizant (gabapentin enacarbil); GlaxoSmithKline; For the treatment of postherpetic neuralgia, Approved June 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
Belviq (lorcaserin hydrochloride); Arena Pharmaceuticals; For the chronic management of weight loss, Approved June 2012
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 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
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
Omontys (peginesatide); Affymax; For the treatment of anemia due to chronic kidney disease, Approved March 2012
Immunology/Infectious Diseases
Horizant (gabapentin enacarbil); GlaxoSmithKline; For the treatment of postherpetic neuralgia, Approved June 2012
Qnasl (beclomethasone dipropionate) nasal aerosol; Teva Pharmaceuticals; For the treatment of seasonal and perennial allergic rhinitis, Approved March 2012
Musculoskeletal
Elelyso (taliglucerase alfa); Pfizer Inc; For the treatment of Gaucher disease, Approved May 2012
Lyrica (pregabalin); Pfizer; For the treatment of neuropathic pain associated with spinal cord injury, Approved June 2012
Myrbetriq (mirabegron); Astellas Pharma US, Inc.; For the treatment of overactive bladder, Approved June 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
Myrbetriq (mirabegron); Astellas Pharma US, Inc.; For the treatment of overactive bladder, Approved June 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
Horizant (gabapentin enacarbil); GlaxoSmithKline; For the treatment of postherpetic neuralgia, Approved June 2012
Lyrica (pregabalin); Pfizer; For the treatment of neuropathic pain associated with spinal cord injury, Approved June 2012
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
Perjeta (pertuzumab); Genentech; For the first-line treatment of HER2+ metastatic breast cancer, Approved June 2012
Oncology
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
Perjeta (pertuzumab); Genentech; For the first-line treatment of HER2+ metastatic breast cancer, Approved June 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
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 Diseases
Dymista (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
Rheumatology
Stendra (avanafil); Vivus; For the treatment of erectile dysfunction, Approved April 2012
Trauma/Emergency Medicine
Lyrica (pregabalin); Pfizer; For the treatment of neuropathic pain associated with spinal cord injury, Approved June 2012
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