Where the Heck is Marinduque?: FDA Approved New Drugs as of June, 2012

Planning to Visit the Philippines Soon?

There are hundreds of tourists attractions in the Philippines. But as a lover of the Island of Marinduque (Home of the Morions and Heart of the Philippines), I am indeed partial to its beauty, charm and its friendly and hospitable residents. Therefore, help me achieve my dream of seeing this island becomes a world tourist destination, by telling all your friends and relatives about this site. Welcome, to you all, new readers and faithful followers of this site! The photo above is Poctoy White Beach in Torrijos, Marinduque with beautiful and majestic Mt Malindig in the background. Some of the photos and videos on this site, I do not own. However, I have no intention on infringing your copyrights.

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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ABOUT ME

I am a retired (Chemistry Team Leader from USFDA) Filipino-American who loves writing, gardening and photography. My wife (of 58 years) and I enjoy the snowbird lifestyle between the US and the Philippines. We have a small but very private beach resort( see above video) in the beautiful island of Marinduque, Philippines. I have several blog sites(ten), a personal blog, blogs about retiring in Marinduque and our beach resort and conference center-CHATEAU DU MER. I also write for www.squidoo.com now owned by HubPages.com

Marinduque: A Photogenic Province and Tourists Destination

Marinduque is a photoblogger dream. The province is endowed with unspoiled white sand beaches, pristine blue waters, fringing reefs, virgin coral reefs, coves, limestone caves, meandering rivers, mountain peaks, cascading waterfalls and streams, fabled sulfur and hot mineral springs,old churches and of course beautiful sunsets. The Internet is filled with photographs of the scenic beauty of this island not only from the local professional photographers but also from amateur photographers all over the world. The province has more than six big islands popular to beach lovers, scuba divers and snorkeling enthusiasts. It has Mt Malindig known to mountain climbers and hikers. It has Bathala and Tarug Caves popular to spelunkers and just curious seekers. In one of the eight caves of Bathala, there is a resident python, believed to be enchanted. If he shows himself when you visit the caves, it is suppose to bring you good luck.

Sunset over Tres Reyes Islands- Photo from panoramnio.com The nearest and most accessible islands from the capital town of Boac are the Tres Reyes Islands ( Islands of the Three Kings), Gaspar, Melchor and Baltazar in the town of Gasan. The local names are Laki, Pangkog and Man-nga ( see map above). These islands are located southwest of the mainland. The other three group of islands bigger in area and more populated are Polo, Maniwaya and Mongpong Islands. These are located in the Northeast part of the mainland in the town of Santa Cruz. Maniwaya's Polo Maria White Beach is being develop as an alternative to Boracay. There is a bigger island, Salamongue Island which is not as well known to the tourists and residents.. I really do not know the reason, but I believe it is not as accessible from the mainland . Moreover, it is not as developed( no electricity or running water) compared to the other islands.

One of the most popular white beach located in the mainland in the town of Torrijos is Poctoy White Beach. It is about a 70 minutes drive from downtown Boac. Poctoy White beach with Mt, Malindig as the background is the most photogenic and the most photographed scenery in the island.

Just late last year, the former Elephant Island in Lipata, Buenavista, owned privately, was renamed Bellarocca Resort Island and Spa. It has been converted to look like Santorini Island, Greece with buildings all painted in white sticking in the cliffs. From what I heard, this resort is one of the most expensive and luxurious resort in Southeast Asia. The cheapest room charges $300 per night excluding meals and other amenities. When I was in Marinduque last year, I met a few rich and famous Filipinos( businessmen, actors and actresses, TV personalities)) from Manila as well as Korean and Japanese tourists at Masiga Airport in Gasan on their way to the resort. From the resort advertisement, I know that the most expensive accommodation is a 3-bedroom villa with its own pool and jacussi charging about $ 800 per night without meals. Dong Ho, Oggie Ramos, Ferdz Decena, Allan Barredo, Sydney Snoeck and Dennis Villegas are some of the photographers that I know who have photo blogs about Marinduque. Their pictures are beautiful, unique and mesmerizing. It is worth your time to visit their photo blogs sites. Looking at their photographs of Marinduque, its Tradition and Culture will surely make you proud of the beauty of our island paradise.

Planning to Visit the Philippines Soon?

Monday, July 23, 2012

FDA Approved New Drugs as of June, 2012

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