FDA Approved New Drugs in 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.