As a retired FDA employee formerly involved in the approval of new drugs, approval of new drugs by the FDA is a subject still close to my heart. Last year ( 2012) had been a very busy year for FDA. More than 200 new drugs in 26 therapeutic areas were approved. The following is a list from www.centerwatch.com for your reading pleasure and information. Consult your physician, if you think one of these new drugs will have more benefits than risks ( side effects) in the treatment of your malady.
1.Cardiology/Vascular Diseases
Eliquis (apixaban); Bristol-Myers Squibb; For the prevention of stroke and systemic embolism resulting from nonvalvular atrial fibrillation, Approved December 2012
Juxtapid (lomitapide); Aegerion Pharmaceuticals; For the treatment of homozygous familial hypercholesterolemia, Approved December of 2012
Vascepa (icosapent ethyl); Amarin Pharmaceuticals; For the treatment of hypertriglyceridemia, Approved July of 2012
2. Dermatology
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
3. Endocrinology
Belviq (lorcaserin hydrochloride); Arena Pharmaceuticals; For the chronic management of weight loss, Approved June 2012
Bio-T-Gel (testosterone gel); Teva Pharmaceutical; For the treatment of hypogonadism, Approved February 2012
Cometriq (cabozantinib); Exelixis; For the treatment of metastatic medullary thyroid cancer, Approved November 2012
Elelyso (taliglucerase alfa); Pfizer; 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
Lucentis (ranibizumab injection); Genentech; For the treatment of diabetic macular edema, Approved August 2012
Qsymia (phentermine + topiramate extended-release); Vivus; For the treatment of chronic weight management, Approved July 2012
Signifor (pasireotide diaspartate); Novartis; For the treatment of Cushing's disease, Approved December of 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
4. Family Medicine
Abraxane (paclitaxel protein-bound particles for injectable suspension); Celgene; For the treatment of non-small cell lung cancer, Approved October 2012
Afinitor (everolimus); Novartis; For the treatment of renal angiomyolipoma associated with tuberous sclerosis complex, Approved April 2012
Afinitor (everolimus); Novartis; For the treatment of hormone receptor-positive, HER2-negative breast cancer, Approved July 2012
Aubagio (teriflunomide); Sanofi Aventis; For the treatment of multiple sclerosis, Approved September 2012
Cometriq (cabozantinib); Exelixis; For the treatment of metastatic medullary thyroid cancer, Approved November 2012
Cystaran (cysteamine hydrochloride); Sigma Tau Pharmaceuticals; For the treatment of corneal cystine crystal accumulation due to cystinosis, Approved October 2012
Dymista (azelastine hydrochloride and fluticasone propionate); Meda Pharmaceuticals Inc.; For the relief of symptoms of seasonal allergic rhinitis, Approved May 2012
Elelyso (taliglucerase alfa); Pfizer; For the treatment of Gaucher disease, Approved May 2012
Erivedge (vismodegib); Genentech; For the treatment of basal cell carcinoma, Approved January 2012
Fycompa (perampanel); Eisai; For the treatment of partial-onset seizures with or without secondarily generalized seizures, Approved October 2012
Horizant (gabapentin enacarbil); GlaxoSmithKline; For the treatment of postherpetic neuralgia, Approved June 2012
Inlyta (axitinib); Pfizer; For the treatment of advanced renal cell carcinoma, Approved January 2012
Jentadueto (linagliptin plus metformin hydrochloride); Eli Lilly; For the treatment of type II diabetes, Approved February 2012
Jetrea (ocriplasmin); Thrombogenics; For the treatment of symptomatic vitreomacular adhesion, Approved October 2012
Korlym (mifepristone); Corcept Therapeutics; For the control of hyperglycemia in adults with endogenous Cushing’s syndrome, Approved February 2012
Kyprolis (carfilzomib); Onyx Pharmaceuticals; For the treatment of multiple myeloma, Approved July 2012
Linzess (linaclotide); Forest Labs and Ironwood Pharmaceuticals; For the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation, Approved August 2012
Lucentis (ranibizumab injection); Genentech; For the treatment of diabetic macular edema, Approved August 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
Natazia (estradiol valerate and estradiol valerate/dienogest); Bayer; For the treatment of heavy menstrual bleeding, Approved March 2012
Neupro (Rotigotine Transdermal System); UCB; For the treatment of Restless Legs Syndrome, Approved April 2012
Omontys (peginesatide); Affymax; For the treatment of anemia due to chronic kidney disease, Approved March 2012
Oxtellar XR (oxcarbazepine extended release); Supernus Pharmaceuticals; For the adjunctive therapy of partial seizures in adults and in children 6 years to 17 years of age, Approved October 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
Qnasl (beclomethasone dipropionate) nasal aerosol; Teva Pharmaceutical; For the treatment of seasonal and perennial allergic rhinitis, Approved March 2012
Quillivant XR (methylphenidate hydrochloride); NextWave Pharmaceuticals; For the treatment of Attention Deficit Hyperactivity Disorder, Approved September 2012
Rayos (prednisone) delayed-release tablets; Horizon Pharma; For the treatment of certain inflammatory diseases, including arthritis, COPD, asthma and psoriatic conditions, Approved July of 2012
Sklice (ivermectin) lotion; Sanofi Pasteur; For the treatment of head lice, Approved February 2012
Stendra (avanafil); Vivus; For the treatment of erectile dysfunction, Approved April 2012
Stivarga (regorafenib); Bayer HealthCare Pharmaceuticals; For the treatment of previously treated patients with metastatic colorectal cancer, Approved September 2012
Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate); Gilead; For the treatment of HIV-1 infection, Approved August 2012
Subsys (fentanyl sublingual spray); Insys Therapeutics; For the treatment of breakthrough cancer pain, Approved January of 2012
Surfaxin (lucinactant); Discovery Laboratories; For the treatment of respiratory distress syndrome in premature infants, Approved March 2012
Tudorza Pressair (aclidinium bromide inhalation powder); Forest Laboratories; For the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, Approved July 2012
Viokace (pancrelipase) tablets; Aptalis Pharma; For the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy, Approved March 2012
Voraxaze (glucarpidase); BTG International; For the treatment of toxic plasma methotrexate concentrations in patients with impaired renal function, Approved January 2012
Xeljanz (tofacitinib); Pfizer; For the treatment of moderately to severely active rheumatoid arthritis, Approved November 2012
Xtandi (enzalutamide); Medivation; For the treatment of metastatic castration-resistant prostate cancer, Approved August 2012
Zaltrap (ziv-aflibercept); Sanofi-aventis; For the treatment of metastatic colorectal cancer, Approved August 2012
Zioptan (tafluprost ophthalmic solution); Merck; For the treatment of elevated intraocular pressure, Approved February 2012
5. Gastroenterology
Elelyso (taliglucerase alfa); Pfizer; For the treatment of Gaucher disease, Approved May 2012
Fulyzaq (crofelemer); Salix Pharmaceuticals; For the treatment of non-infectious diarrhea in adults with HIV/AIDS, Approved December 2012
Gattex (teduglutide); NPS Pharmaceuticals; For the treatment of short bowel syndrome, Approved December 2012
Linzess (linaclotide); Forest Labs and Ironwood Pharmaceuticals; For the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation, Approved August 2012
Stivarga (regorafenib); Bayer HealthCare Pharmaceuticals; For the treatment of previously treated patients with metastatic colorectal cancer, Approved September 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
Xtandi (enzalutamide); Medivation; For the treatment of metastatic castration-resistant prostate cancer, Approved August 2012
Zaltrap (ziv-aflibercept); Sanofi-aventis; For the treatment of metastatic colorectal cancer, Approved August 2012
6. Genetic Disease
Elelyso (taliglucerase alfa); Pfizer; For the treatment of Gaucher disease, Approved May 2012
Fycompa (perampanel); Eisai; For the treatment of partial-onset seizures with or without secondarily generalized seizures, Approved October 2012
Juxtapid (lomitapide); Aegerion Pharmaceuticals; For the treatment of homozygous familial hypercholesterolemia, Approved December of 2012
Kalydeco (ivacaftor); Vertex Pharmaceuticals; For the treatment of cystic fibrosis with the G551D mutation in the CFTR gene, Approved January of 2012
Oxtellar XR (oxcarbazepine extended release); Supernus Pharmaceuticals; For the adjunctive therapy of partial seizures in adults and in children 6 years to 17 years of age, Approved October 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
7. Hematology
Bosulif (bosutinib); Pfizer; For the treatment of Ph+ chronic myelogenous leukemia, Approved September 2012
Elelyso (taliglucerase alfa); Pfizer; For the treatment of Gaucher disease, Approved May 2012
Iclusig (ponatinib); Ariad Pharmaceuticals; For the treatment of chronic myeloid leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia, Approved December 2012
Kyprolis (carfilzomib); Onyx Pharmaceuticals; For the treatment of multiple myeloma, Approved July 2012
Marqibo (vinCRIStine sulfate LIPOSOME injection); Talon Therapeutics; For the treatment of Ph- acute lymphoblastic leukemia, Approved August 2012
Neutroval (tbo-filgrastim); Teva Pharmaceutical; For the reduction in the duration of severe chemotherapy-induced neutropenia, Approved August 2012
Omontys (peginesatide); Affymax; For the treatment of anemia due to chronic kidney disease, Approved March 2012
Synribo (omacetaxine mepesuccinate); Teva Pharmaceutical; For the treatment of chronic or accelerated phase chronic myeloid leukemia, Approved October 2012
8. Hepatology (Liver, Pancreatic, Gall Bladder)
Inlyta (axitinib); Pfizer; For the treatment of advanced renal cell carcinoma, Approved January 2012
Kalydeco (ivacaftor); Vertex Pharmaceuticals; For the treatment of cystic fibrosis with the G551D mutation in the CFTR gene, Approved January of 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
9. Immunology
Flucelvax, Influenza Virus Vaccine; Novartis; For the treatment of influenza virus subtypes A and type B, Approved November 2012
Fulyzaq (crofelemer); Salix Pharmaceuticals; For the treatment of non-infectious diarrhea in adults with HIV/AIDS, Approved December 2012
Horizant (gabapentin enacarbil); GlaxoSmithKline; For the treatment of postherpetic neuralgia, Approved June 2012
Qnasl (beclomethasone dipropionate) nasal aerosol; Teva Pharmaceutical; For the treatment of seasonal and perennial allergic rhinitis, Approved March 2012
Rayos (prednisone) delayed-release tablets; Horizon Pharma; For the treatment of certain inflammatory diseases, including arthritis, COPD, asthma and psoriatic conditions, Approved July of 2012
Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate); Gilead; For the treatment of HIV-1 infection, Approved August 2012
Tudorza Pressair (aclidinium bromide inhalation powder); Forest Laboratories; For the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, Approved July 2012
10. Infections and Infectious Diseases
Abthrax (raxibacumab); GlaxoSmithKline; For the treatment and prevention of anthrax, Approved December of 2012
Afinitor (everolimus); Novartis; For the treatment of renal angiomyolipoma associated with tuberous sclerosis complex, Approved April 2012
Cystaran (cysteamine hydrochloride); Sigma Tau Pharmaceuticals; For the treatment of corneal cystine crystal accumulation due to cystinosis, Approved October 2012
Dymista (azelastine hydrochloride and fluticasone propionate); Meda Pharmaceuticals Inc.; For the relief of symptoms of seasonal allergic rhinitis, Approved May 2012
Flucelvax, Influenza Virus Vaccine; Novartis; For the treatment of influenza virus subtypes A and type B, Approved November 2012
Fulyzaq (crofelemer); Salix Pharmaceuticals; For the treatment of non-infectious diarrhea in adults with HIV/AIDS, Approved December 2012
Jetrea (ocriplasmin); Thrombogenics; For the treatment of symptomatic vitreomacular adhesion, Approved October 2012
Linzess (linaclotide); Forest Labs and Ironwood Pharmaceuticals; For the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation, Approved August 2012
Qnasl (beclomethasone dipropionate) nasal aerosol; Teva Pharmaceutical; For the treatment of seasonal and perennial allergic rhinitis, Approved March 2012
Sirturo (bedaquiline); Janssen Therapeutics; For the treatment of multi-drug resistant tuberculosis, Approved December 2012
Sklice (ivermectin) lotion; Sanofi Pasteur; For the treatment of head lice, Approved February 2012
Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate); Gilead; For the treatment of HIV-1 infection, Approved August 2012
Tudorza Pressair (aclidinium bromide inhalation powder); Forest Laboratories; For the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, Approved July 2012
11. Musculoskeletal
Aubagio (teriflunomide); Sanofi Aventis; For the treatment of multiple sclerosis, Approved September 2012
Elelyso (taliglucerase alfa); Pfizer; 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
Rayos (prednisone) delayed-release tablets; Horizon Pharma; For the treatment of certain inflammatory diseases, including arthritis, COPD, asthma and psoriatic conditions, Approved July of 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
Xeljanz (tofacitinib); Pfizer; For the treatment of moderately to severely active rheumatoid arthritis, Approved November 2012
12. Nephrology
Afinitor (everolimus); Novartis; 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
Stivarga (regorafenib); Bayer HealthCare Pharmaceuticals; For the treatment of previously treated patients with metastatic colorectal cancer, Approved September 2012
Voraxaze (glucarpidase); BTG International; For the treatment of toxic plasma methotrexate concentrations in patients with impaired renal function, Approved January 2012
13. Neurology
Eliquis (apixaban); Bristol-Myers Squibb; For the prevention of stroke and systemic embolism resulting from nonvalvular atrial fibrillation, Approved December 2012
Fycompa (perampanel); Eisai; For the treatment of partial-onset seizures with or without secondarily generalized seizures, Approved October 2012
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
Oxtellar XR (oxcarbazepine extended release); Supernus Pharmaceuticals; For the adjunctive therapy of partial seizures in adults and in children 6 years to 17 years of age, Approved October 2012
Quillivant XR (methylphenidate hydrochloride); NextWave Pharmaceuticals; For the treatment of Attention Deficit Hyperactivity Disorder, Approved September 2012
Subsys (fentanyl sublingual spray); Insys Therapeutics; For the treatment of breakthrough cancer pain, Approved January of 2012
14. Nutrition and Weight Loss
Belviq (lorcaserin hydrochloride); Arena Pharmaceuticals; For the chronic management of weight loss, Approved June 2012
Qsymia (phentermine + topiramate extended-release); Vivus; For the treatment of chronic weight management, Approved July 2012
15. Obstetrics/Gynecology (Women’s Health)
Afinitor (everolimus); Novartis; For the treatment of hormone receptor-positive, HER2-negative breast cancer, Approved July 2012
Natazia (estradiol valerate and estradiol valerate/dienogest); Bayer; 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
16. Oncology
Abraxane (paclitaxel protein-bound particles for injectable suspension); Celgene; For the treatment of non-small cell lung cancer, Approved October 2012
Afinitor (everolimus); Novartis; For the treatment of hormone receptor-positive, HER2-negative breast cancer, Approved July 2012
Afinitor (everolimus); Novartis; For the treatment of renal angiomyolipoma associated with tuberous sclerosis complex, Approved April 2012
Bosulif (bosutinib); Pfizer; For the treatment of Ph+ chronic myelogenous leukemia, Approved September 2012
Cometriq (cabozantinib); Exelixis; For the treatment of metastatic medullary thyroid cancer, Approved November 2012
Erivedge (vismodegib); Genentech; For the treatment of basal cell carcinoma, Approved January 2012
Iclusig (ponatinib); Ariad Pharmaceuticals; For the treatment of chronic myeloid leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia, Approved December 2012
Inlyta (axitinib); Pfizer; For the treatment of advanced renal cell carcinoma, Approved January 2012
Kyprolis (carfilzomib); Onyx Pharmaceuticals; For the treatment of multiple myeloma, Approved July 2012
Marqibo (vinCRIStine sulfate LIPOSOME injection); Talon Therapeutics; For the treatment of Ph- acute lymphoblastic leukemia, Approved August 2012
Neutroval (tbo-filgrastim); Teva Pharmaceutical; For the reduction in the duration of severe chemotherapy-induced neutropenia, Approved August 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
Stivarga (regorafenib); Bayer HealthCare Pharmaceuticals; For the treatment of previously treated patients with metastatic colorectal cancer, Approved September 2012
Subsys (fentanyl sublingual spray); Insys Therapeutics; For the treatment of breakthrough cancer pain, Approved January of 2012
Synribo (omacetaxine mepesuccinate); Teva Pharmaceutical; For the treatment of chronic or accelerated phase chronic myeloid leukemia, Approved October 2012
Votrient (pazopanib); GlaxoSmithKline; For the treatment of soft tissue sarcoma, Approved April 2012
Xtandi (enzalutamide); Medivation; For the treatment of metastatic castration-resistant prostate cancer, Approved August 2012
Zaltrap (ziv-aflibercept); Sanofi-aventis; For the treatment of metastatic colorectal cancer, Approved August 2012
17. Ophthalmology
Cystaran (cysteamine hydrochloride); Sigma Tau Pharmaceuticals; For the treatment of corneal cystine crystal accumulation due to cystinosis, Approved October 2012
Jetrea (ocriplasmin); Thrombogenics; For the treatment of symptomatic vitreomacular adhesion, Approved October 2012
Lucentis (ranibizumab injection); Genentech; For the treatment of diabetic macular edema, Approved August 2012
Zioptan (tafluprost ophthalmic solution); Merck; For the treatment of elevated intraocular pressure, Approved February 2012
18. Orthopedics/Orthopedic Surgery
Rayos (prednisone) delayed-release tablets; Horizon Pharma; For the treatment of certain inflammatory diseases, including arthritis, COPD, asthma and psoriatic conditions, Approved July of 2012
19. Otolaryngology (Ear, Nose, Throat)
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 Pharmaceutical; For the treatment of seasonal and perennial allergic rhinitis, Approved March 2012
20. Pediatrics/Neonatology
Fycompa (perampanel); Eisai; For the treatment of partial-onset seizures with or without secondarily generalized seizures, Approved October 2012
Oxtellar XR (oxcarbazepine extended release); Supernus Pharmaceuticals; For the adjunctive therapy of partial seizures in adults and in children 6 years to 17 years of age, Approved October 2012
Qnasl (beclomethasone dipropionate) nasal aerosol; Teva Pharmaceutical; For the treatment of seasonal and perennial allergic rhinitis, Approved March 2012
Quillivant XR (methylphenidate hydrochloride); NextWave Pharmaceuticals; For the treatment of Attention Deficit Hyperactivity Disorder, Approved September 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
21. Pharmacology/Toxicology
Voraxaze (glucarpidase); BTG International; For the treatment of toxic plasma methotrexate concentrations in patients with impaired renal function, Approved January 2012
22. Psychiatry/Psychology
Qsymia (phentermine + topiramate extended-release); Vivus; For the treatment of chronic weight management, Approved July 2012
Quillivant XR (methylphenidate hydrochloride); NextWave Pharmaceuticals; For the treatment of Attention Deficit Hyperactivity Disorder, Approved September 2012
23. Pulmonary/Respiratory Diseases
Abraxane (paclitaxel protein-bound particles for injectable suspension); Celgene; For the treatment of non-small cell lung cancer, Approved October 2012
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 Pharmaceutical; For the treatment of seasonal and perennial allergic rhinitis, Approved March 2012
Rayos (prednisone) delayed-release tablets; Horizon Pharma; For the treatment of certain inflammatory diseases, including arthritis, COPD, asthma and psoriatic conditions, Approved July of 2012
Sirturo (bedaquiline); Janssen Therapeutics; For the treatment of multi-drug resistant tuberculosis, Approved December 2012
Surfaxin (lucinactant); Discovery Laboratories; For the treatment of respiratory distress syndrome in premature infants, Approved March 2012
Tudorza Pressair (aclidinium bromide inhalation powder); Forest Laboratories; For the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, Approved July 2012
24. Rheumatology
Rayos (prednisone) delayed-release tablets; Horizon Pharma; For the treatment of certain inflammatory diseases, including arthritis, COPD, asthma and psoriatic conditions, Approved July of 2012
Stendra (avanafil); Vivus; For the treatment of erectile dysfunction, Approved April 2012
Xeljanz (tofacitinib); Pfizer; For the treatment of moderately to severely active rheumatoid arthritis, Approved November 2012
Trauma (Emergency, Injury, Surgery)
Lyrica (pregabalin); Pfizer; For the treatment of neuropathic pain associated with spinal cord injury, Approved June 2012
25. Urology
Bio-T-Gel (testosterone gel); Teva Pharmaceutical; For the treatment of hypogonadism, Approved February 2012
Myrbetriq (mirabegron); Astellas Pharma US, Inc.; For the treatment of overactive bladder, Approved June 2012
Stendra (avanafil); Vivus; For the treatment of erectile dysfunction, Approved April 2012
Xtandi (enzalutamide); Medivation; For the treatment of metastatic castration-resistant prostate cancer, Approved August 2012
26. Vaccines
Flucelvax, Influenza Virus Vaccine; Novartis; For the treatment of influenza virus subtypes A and type B, Approved November 2012
Horizant (gabapentin enacarbil); GlaxoSmithKline; For the treatment of postherpetic neuralgia, Approved June 2012
Personal Note: I was the Chemistry Team Leader in the Division of Anti-Infective Drug Products, New Drug Chemistry, prior to my retirement from FDA in 2002. I was responsible for all the Chemistry, Manufacturing and Control (CMC) requirements for all new drugs prior to approval supervising the work of 5 to 6 Chemistry Reviewers.
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