WELCOME TO CHATEAU DU MER BEACH RESORT

If this is your first time in my site, welcome! Chateau Du Mer is a beach resort with a beach house and conference Hall. The beach house could now accommodate 10 guests, six in the main floor and four in the first floor( air conditioned room). In addition, you can now reserve your vacation dates ahead and pay the rental fees via PayPal. I hope to see you soon in Marinduque- Home of the Morions and Heart of the Philippines. The photo above was taken during our first Garden Wedding ceremony at The Chateau Du Mer Gardens. You can now read the national and international news in this blog at the right side bar. I have also posted my favorite Filipino and American dishes and recipes in this site. Some of the photos and videos on this site, I do not own, but I have no intention on the infringement of your copyrights!

Marinduque Mainland from Tres Reyes Islands

Marinduque Mainland from Tres Reyes Islands
View of Marinduque Mainland from Tres Reyes Islands-Click on photo to link to Marinduque Awaits You

Thursday, June 20, 2013

FDA Approved New Drugs for 2012


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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