Copyright 2009 Medical News Today Latest Regulatory Affairs / Drug Approvals News From Medical News Today. http://www.medicalnewstoday.com/sections/regulatoryaffairs/ admin@medicalnewstoday.com (MNT Admin) editors@medicalnewstoday.com (MNT Editors) en-us Fri, 20 Nov 2009 23:00:00 PST http://www.medicalnewstoday.com/articles/171723.php http://www.medicalnewstoday.com/articles/171723.php Anika Therapeutics, Inc. (Nasdaq: ANIK), a leader in products for tissue protection, healing and repair based on hyaluronic acid ("HA") technology, announced that it has received European CE Mark approval for "ELEVESS™ Light," the Company's latest aesthetic product used for the treatment of fine lines and facial wrinkles. Dermatology Fri, 20 Nov 2009 18:00:00 PST http://www.medicalnewstoday.com/articles/171710.php http://www.medicalnewstoday.com/articles/171710.php The U.S. Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee voted 11 to 1 that clinical data included in a supplemental new drug application (sNDA) provide substantial and convincing evidence to support the claim that SPIRIVA® HandiHaler® (tiotropium bromide inhalation powder) reduces exacerbations (worsening of symptoms) in patients with chronic obstructive pulmonary disease (COPD). COPD Fri, 20 Nov 2009 04:00:00 PST http://www.medicalnewstoday.com/articles/171659.php http://www.medicalnewstoday.com/articles/171659.php The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against William F. Nickle of North East, Md., for allegedly selling veal calves for human consumption that contained illegal drug residues in edible tissues. The complaint, filed Nov. 13, 2009, in the U.S. District Court for the District of Maryland, also alleges that Mr. Litigation / Medical Malpractice Fri, 20 Nov 2009 03:00:00 PST http://www.medicalnewstoday.com/articles/171656.php http://www.medicalnewstoday.com/articles/171656.php The U.S. Food and Drug Administration completed a coordinated, weeklong, international effort, called the International Internet Week of Action (IIWA), intended to curb illegal actions involving medical products. IT / Internet / E-mail Fri, 20 Nov 2009 00:00:00 PST http://www.medicalnewstoday.com/articles/171558.php http://www.medicalnewstoday.com/articles/171558.php Sandra Eskin, director of the Pew Health Group's Food Safety Campaign, has issued the following statement regarding the markup of the FDA Food Safety Modernization Act by the Senate Health, Education, Labor, & Pensions Committee: "The Pew Health Group applauds the members of the Senate Health, Education, Labor, & Pensions (HELP) Committee for approving the FDA Food Safety Modernization Act (S. 510) today. Nutrition / Diet Fri, 20 Nov 2009 00:00:00 PST http://www.medicalnewstoday.com/articles/171573.php http://www.medicalnewstoday.com/articles/171573.php The European Medicines Agency has been formally notified by Otsuka Pharmaceutical Europe Ltd of its decision to withdraw its application for an extension of indication for the centrally authorised medicine Abilify (aripiprazole) tablets, orodispersible tablets and oral solution. Abilify was expected to be used in the treatment of major depressive episodes, as adjunctive therapy, in patients who have had an inadequate response to previous treatment with antidepressants. Psychology / Psychiatry Thu, 19 Nov 2009 22:00:00 PST http://www.medicalnewstoday.com/articles/171559.php http://www.medicalnewstoday.com/articles/171559.php Spineology Inc., developer and manufacturer of minimally invasive spinal surgery devices, announced today that it has received FDA clearance for its minimally invasive surgery (MIS) Capture™ Facet Screw System. The Capture System was developed by Spineology in mid-2009 under the direction of Dr. Chet Sutterlin, product development consultant. Neurology / Neuroscience Thu, 19 Nov 2009 21:00:00 PST http://www.medicalnewstoday.com/articles/171557.php http://www.medicalnewstoday.com/articles/171557.php Guided Therapy Systems, LLC (GTS), a leading medical technology company, is the first company in the world to develop and commercialize products that employ a unique form of ultrasound technology, Intense Therapeutic Ultrasound (ITU). Addressing a $4 billion market, the company's patented products combine ultrasound imaging with ultrasound treatment in a single non-invasive "see and treat" device. The "see" capability allows physicians to see into the body without surgery. MRI / PET / Ultrasound Thu, 19 Nov 2009 20:00:00 PST http://www.medicalnewstoday.com/articles/171555.php http://www.medicalnewstoday.com/articles/171555.php Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec (Nasdaq: BIIB) announced today that the U.S. Food and Drug Administration (FDA) issued a complete response on the companies' applications for Rituxan® (rituximab) plus fludarabine and cyclophosphamide (FC) for the treatment of people with previously untreated and previously treated chronic lymphocytic leukemia (CLL). Lymphoma / Leukemia / Myeloma Thu, 19 Nov 2009 19:00:00 PST http://www.medicalnewstoday.com/articles/171552.php http://www.medicalnewstoday.com/articles/171552.php Pfizer Inc (NYSE:PFE) announced today that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee voted 10 to 1 that the data presented support the safety and effectiveness of its 13-valent pneumococcal conjugate candidate vaccine, Prevnar 13™ (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), for the prevention of invasive pneumococcal disease in infants and young children. Immune System / Vaccines Thu, 19 Nov 2009 04:00:00 PST http://www.medicalnewstoday.com/articles/171505.php http://www.medicalnewstoday.com/articles/171505.php Patients should avoid using the stomach acid reducer Prilosec/Prilosec OTC (omeprazole) with the anti-clotting drug Plavix (clopidogrel), the U.S. Food and Drug Administration warned on Nov. 17. New data suggest that when patients take both Prilosec and Plavix, Plavix's ability to block platelet aggregation (anti-clotting effect) may be reduced by about half. "Both of these drugs, when used properly, provide significant benefits to patients. Blood / Hematology Thu, 19 Nov 2009 04:00:00 PST http://www.medicalnewstoday.com/articles/171507.php http://www.medicalnewstoday.com/articles/171507.php On Nov. 16, 2009, Judge Marvin J. Garbis of the United States District Court for the District of Maryland entered a Consent Decree of Permanent Injunction (Decree) against Old Carolina Farm and its owner, Francis Roderick, of Ijamsville, Md. The Decree prohibits the defendants from selling animals for slaughter for human consumption until they have implemented record keeping systems that will identify and track animals that have been treated with drugs. Water - Air Quality / Agriculture Thu, 19 Nov 2009 02:00:00 PST http://www.medicalnewstoday.com/articles/171450.php http://www.medicalnewstoday.com/articles/171450.php Endologix, Inc. Vascular Wed, 18 Nov 2009 19:00:00 PST http://www.medicalnewstoday.com/articles/171386.php http://www.medicalnewstoday.com/articles/171386.php SafeStitch Medical, Inc. (OTCBB:SFES) announced that it has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") to market its AMID StaplerTM in the U.S. with the intended use in general surgery procedures for fixation of mesh, in the repair of hernia defects and in other surgical specialties for the approximation of tissues, including skin. Cosmetic Medicine / Plastic Surgery Wed, 18 Nov 2009 15:00:00 PST http://www.medicalnewstoday.com/articles/171378.php http://www.medicalnewstoday.com/articles/171378.php Pfizer Inc (NYSE:PFE) announced it has submitted pediatric data for Lipitor® (atorvastatin) to the European Medicines Agency (EMEA). Pfizer has also developed a new chewable form of Lipitor, including a pediatric-appropriate 5 mg dose, which is part of this submission. Pediatrics / Children's Health Wed, 18 Nov 2009 09:00:00 PST http://www.medicalnewstoday.com/articles/171358.php http://www.medicalnewstoday.com/articles/171358.php Basilea Pharmaceutica Ltd. announces that Toctino® (alitretinoin), a new once-daily oral treatment for adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids, has obtained regulatory approval from Health Canada. "We are delighted that Health Canada has approved the use of Toctino for patients with severe chronic hand eczema unresponsive to potent topical steroids. Eczema / Psoriasis Wed, 18 Nov 2009 04:00:00 PST http://www.medicalnewstoday.com/articles/171332.php http://www.medicalnewstoday.com/articles/171332.php The Food and Drug Administration (FDA) has approved the approval of Qutenza (capsaicin) 8% patch, a medicated skin patch that relieves the pain of post-herpetic neuralgia (PHN), a serious complication that can occur after a bout with shingles. Shingles is an outbreak of rash or blisters on the skin that is caused by the same virus that causes chickenpox - the varicella-zoster virus. Pain / Anesthetics Wed, 18 Nov 2009 03:00:00 PST http://www.medicalnewstoday.com/articles/171290.php http://www.medicalnewstoday.com/articles/171290.php Fenwal, Inc., a global medical technology company focused on improving blood collection, separation, safety and availability, announced that the U.S. Food and Drug Administration has cleared the Verax Platelet PGD® test as a quality control test to detect bacterial contamination in whole blood-derived, pooled platelets prior to transfusion. Fenwal is the exclusive global distributor of the test, which was developed by Verax Biomedical of Worcester, Mass. Infectious Diseases / Bacteria / Viruses Wed, 18 Nov 2009 03:00:00 PST http://www.medicalnewstoday.com/articles/171291.php http://www.medicalnewstoday.com/articles/171291.php NeurogesX, Inc. (Nasdaq: NGSX) announces that it will hold a conference call at 8:30a.m. ET (5:30a.m. PT) to discuss the U.S. Food and Drug Administration (FDA) approval of Qutenza(TM) (capsaicin) 8% patch, the first and only product containing prescription strength capsaicin, for the management of neuropathic pain due to postherpetic neuralgia (PHN), the nerve pain which can follow shingles. Pain / Anesthetics Wed, 18 Nov 2009 01:00:00 PST http://www.medicalnewstoday.com/articles/171252.php http://www.medicalnewstoday.com/articles/171252.php In one of the few studies of the long-term effects of medication in the treatment of pulmonary arterial hypertension (PAH) disease, a team of researchers found the health and exercise capacity of PAH patients improved after two years of treatment with ambrisentan, according to a study published in the current edition of the Journal of the American College of Cardiology. Cardiovascular / Cardiology Wed, 18 Nov 2009 00:00:00 PST http://www.medicalnewstoday.com/articles/171239.php http://www.medicalnewstoday.com/articles/171239.php Covidien (NYSE: COV) announced that on November 13, 2009, representatives of Neuromed discussed the pending New Drug Application (NDA) for the product candidate ExalgoTM (hydromorphone HCl extended release) tablets with staff from the United States Food and Drug Administration (FDA). Mallinckrodt Inc., a Covidien company, obtained the commercial rights to Exalgo in the United States from Neuromed Development Inc., a subsidiary of Neuromed Pharmaceuticals Ltd., in June 2009. Pain / Anesthetics Tue, 17 Nov 2009 23:00:00 PST http://www.medicalnewstoday.com/articles/171210.php http://www.medicalnewstoday.com/articles/171210.php Oculus Innovative Sciences, Inc. Veterinary Tue, 17 Nov 2009 06:00:00 PST http://www.medicalnewstoday.com/articles/171215.php http://www.medicalnewstoday.com/articles/171215.php Cerus Corporation (NASDAQ:CERS) announced that the FDA's Blood Products Advisory Committee (BPAC) rendered a positive opinion on the proposed hemostatic efficacy and safety endpoints for a potential U.S. Phase III clinical trial of the INTERCEPT Blood System for platelets. Blood / Hematology Tue, 17 Nov 2009 06:00:00 PST http://www.medicalnewstoday.com/articles/171217.php http://www.medicalnewstoday.com/articles/171217.php Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the company submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Avastin® (bevacizumab) for the treatment of women who have not received chemotherapy for advanced (metastatic) HER2-negative breast cancer (first-line treatment). Breast Cancer Tue, 17 Nov 2009 06:00:00 PST http://www.medicalnewstoday.com/articles/171218.php http://www.medicalnewstoday.com/articles/171218.php An overwhelming majority of Wyoming voters - 88 percent - support food safety legislation that would give the Food and Drug Administration (FDA) new authority to ensure the food Americans eat does not make them sick, according to a new poll commissioned by the Pew Health Group and conducted by Hart Research and Public Opinion Strategies. Support for stronger food protections is high regardless of voters' gender, income level or political affiliation. Nutrition / Diet