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If you love Marinduque and want to contribute articles to this site, please do so. My contact information is in my profile. The above photo was taken from the balcony of The Chateau Du Mer Beach House, Boac, Marindque, Philippines. I love sunsets. How about you? Please do not forget to read the latest national and international news in the right side bar of this blog. Some of the photos and videos on this site, I do not own. However, I have no intention on infringing your copyrights. Thank you and Cheers!

Tres Reyes Island view of the Marinduque Mainland

Monday, July 23, 2012

FDA Approved New Drugs as of June, 2012

A Brain Scan of a Normal Brain versus the Brain of the Person with Alzheimer's

If you been reading my blogs, you probably already know that I am a retired Chemistry Team Leader from FDA, Center of New Drugs. When I retired in 2002, I did not accept any consultancy ( some of my colleagues did) since I wanted to devote my time in building a small beach resort in Marinduque, Philippines. However, I had been watching development of new drugs and had been impressed by the number and high quality of the new therapies approved by FDA since 2002. The following is a list of new drugs approved as of June this year. By the end of the year, I am expecting with high hopes that three more drugs for the cure of Alzheimer's disease will be approved and can be included in this list. Note that there are no anti-infective and anti-viral drugs in this current list.

FDA Approved Drugs as of June, 2012 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, date of approval, indication of use, and the pharmaceutical company sponsor.( www.centerwatch.com).

Dermatology/Plastic Surgery: 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, 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, 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, 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, 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.

I hope you find this list useful and informative.

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