FDA Approval Drugs-2012
Dermatology/Plastic Surgery
Erivedge
(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
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 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
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
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
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 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
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