http://www.disabled-world.com/ Disability Community News and Information Wed, 09 May 2012 09:11:39 EST en-us http://www.disabled-world.com/medical/pharmaceutical/fda/intermezzo.php FDA Approvals FDA Approves First Insomnia Drug for Middle-of-the-Night Waking Followed By Difficulty Returning to Sleep. Fri, 25 Nov 2011 16:18:57 EST http://www.disabled-world.com/medical/pharmaceutical/fda/intermezzo.php http://www.disabled-world.com/medical/pharmaceutical/fda/cialis.php FDA Approvals The U.S. Food and Drug Administration approves Cialis (tadalafil) to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition in which the prostate gland becomes enlarged, and for the treatment of BPH and erectile dysfunction (ED), when the conditions occur simultaneously. Cialis was approved in 2003 for the treatment of ED. Thu, 13 Oct 2011 14:41:03 EST http://www.disabled-world.com/medical/pharmaceutical/fda/cialis.php http://www.disabled-world.com/medical/pharmaceutical/fda/boostrix.php FDA Approvals FDA Approves Boostrix to Prevent Tetanus, Diphtheria, and Pertussis in Older People. Sun, 10 Jul 2011 14:25:50 EST http://www.disabled-world.com/medical/pharmaceutical/fda/boostrix.php http://www.disabled-world.com/medical/pharmaceutical/fda/lazanda-fentanyl.php FDA Approvals On Average, More than Half of Patients with Cancer Experience Debilitating Breakthrough Pain. Thu, 30 Jun 2011 18:52:02 EST http://www.disabled-world.com/medical/pharmaceutical/fda/lazanda-fentanyl.php http://www.disabled-world.com/medical/pharmaceutical/fda/fda-global-strategy.php FDA Approvals FDA Unveils New Global Strategy to Help Ensure Safety and Quality of Imported Products - Strategy calls for coalitions of international regulators, increased data sharing. Mon, 20 Jun 2011 13:51:42 EST http://www.disabled-world.com/medical/pharmaceutical/fda/fda-global-strategy.php http://www.disabled-world.com/medical/pharmaceutical/fda/injectable-gel.php FDA Approvals The U.S. Food and Drug Administration today approved a sterile, injectable gel to treat fecal incontinence in patients for whom other therapies such as diet change, fiber therapy or anti-motility medications failed. Sat, 28 May 2011 13:20:36 EST http://www.disabled-world.com/medical/pharmaceutical/fda/injectable-gel.php http://www.disabled-world.com/medical/pharmaceutical/fda/toxoplasmosis.php FDA Approvals FDA clears first test for recent infection with toxoplasmosis parasite. Tue, 24 May 2011 18:11:03 EST http://www.disabled-world.com/medical/pharmaceutical/fda/toxoplasmosis.php http://www.disabled-world.com/medical/pharmaceutical/fda/sutent.php FDA Approvals The U.S. Food and Drug Administration has approved Sutent (sunitinib) to treat patients with progressive neuroendocrine cancerous tumors located in the pancreas that cannot be removed by surgery or that have spread to other parts of the body (metastatic). Sun, 22 May 2011 17:14:03 EST http://www.disabled-world.com/medical/pharmaceutical/fda/sutent.php http://www.disabled-world.com/medical/pharmaceutical/fda/q-fever.php FDA Approvals The U.S. Food and Drug Administration today cleared the first nucleic acid amplification test to diagnose the early stages of Q fever infections in military personnel serving overseas. Sun, 22 May 2011 17:02:15 EST http://www.disabled-world.com/medical/pharmaceutical/fda/q-fever.php http://www.disabled-world.com/medical/pharmaceutical/fda/edurant.php FDA Approvals The U.S. Food and Drug Administration today approved Edurant (rilpivirine) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy (treatment-naive). Fri, 20 May 2011 18:27:00 EST http://www.disabled-world.com/medical/pharmaceutical/fda/edurant.php http://www.disabled-world.com/medical/pharmaceutical/fda/victrelis.php FDA Approvals The safety and effectiveness of Victrelis was evaluated in two phase 3 clinical trials with 1,500 adult patients. Sat, 14 May 2011 15:46:11 EST http://www.disabled-world.com/medical/pharmaceutical/fda/victrelis.php http://www.disabled-world.com/medical/pharmaceutical/fda/linagliptin.php FDA Approvals First DPP4 inhibitor approved at one dosage strength; no dose adjustment recommended for patients with type 2 diabetes who have kidney or liver impairment. Tue, 03 May 2011 13:12:02 EST http://www.disabled-world.com/medical/pharmaceutical/fda/linagliptin.php http://www.disabled-world.com/health/neurology/sleepdisorders/restlesslegsyndrome/horizant.php Restless Legs Syndrome On April 6, the U.S. Food and Drug Administration approved Horizant Extended Release Tablets (gabapentin enacarbil), a once-daily treatment for moderate-to-severe restless legs syndrome (RLS). Sun, 10 Apr 2011 12:49:07 EST http://www.disabled-world.com/health/neurology/sleepdisorders/restlesslegsyndrome/horizant.php http://www.disabled-world.com/medical/pharmaceutical/fda/vending-machine-labeling.php FDA Approvals The U.S. Food and Drug Administration today issued two proposed regulations regarding calorie labeling on menus and menu boards in chain restaurants, retail food establishments, and vending machines. Fri, 01 Apr 2011 16:43:24 EST http://www.disabled-world.com/medical/pharmaceutical/fda/vending-machine-labeling.php http://www.disabled-world.com/medical/pharmaceutical/fda/ipilimumab.php FDA Approvals The U.S. Food and Drug Administration today approved Yervoy (ipilimumab) to treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer. Mon, 28 Mar 2011 16:02:36 EST http://www.disabled-world.com/medical/pharmaceutical/fda/ipilimumab.php http://www.disabled-world.com/medical/pharmaceutical/fda/zostavax.php FDA Approvals FDA Approves Zostavax Vaccine to Prevent Shingles in Individuals 50 to 59 Years of Age. Fri, 25 Mar 2011 12:19:36 EST http://www.disabled-world.com/medical/pharmaceutical/fda/zostavax.php http://www.disabled-world.com/medical/pharmaceutical/fda/edarbi.php FDA Approvals The U.S. Food and Drug Administration today approved Edarbi tablets (azilsartan medoxomil) to treat high blood pressure (hypertension) in adults. Sat, 26 Feb 2011 16:48:43 EST http://www.disabled-world.com/medical/pharmaceutical/fda/edarbi.php http://www.disabled-world.com/medical/pharmaceutical/fda/neuralstem-als.php FDA Approvals Neuralstem, Inc. announced that the U.S. Food and Drug Administration's Office of Orphan Products Development has granted it orphan drug designation for the treatment of Amyotrophic Lateral Sclerosis (ALS) with its human spinal cord derived neural stem cells (NSI-566RSC), currently in a Phase I safety study to evaluate the safety of the product and the surgical route of administration in a wide range of ALS patients. Mon, 14 Feb 2011 10:31:07 EST http://www.disabled-world.com/medical/pharmaceutical/fda/neuralstem-als.php http://www.disabled-world.com/medical/pharmaceutical/fda/viibryd.php FDA Approvals The U.S. Food and Drug Administration today approved Viibryd tablets (vilazodone hydrochloride) to treat major depressive disorder in adults. Sat, 22 Jan 2011 16:05:26 EST http://www.disabled-world.com/medical/pharmaceutical/fda/viibryd.php http://www.disabled-world.com/medical/pharmaceutical/fda/head-lice-treatment.php FDA Approvals The U.S. Food and Drug Administration today approved Natroba (spinosad) Topical Suspension 0.9% for the treatment of head lice infestation in patients ages 4 years and older. Tue, 18 Jan 2011 17:05:53 EST http://www.disabled-world.com/medical/pharmaceutical/fda/head-lice-treatment.php