2012 FDA-Approved New Drugs
The following database contains a
listing of drugs approved by the Food and Drug Administration (FDA) for sale in
the United States. Drug information typically includes the drug name, approval
status, indication of use, and clinical trial results. Review descriptions for our medical therapeutic area list to
help assist in your search.
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Find out more about the types of drugs included in this listing.
2012
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
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
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
