FDA News
Hasta La Vista, Meridia: Another Diet Drug Bites the Dust
Abbott’s removal of Meridia from the U.S. market — at the FDA’s request — means there’s just one weight-loss therapy approved for long-term use in a country where 68% of the population is overweight or obese. (As the WSJ reports, Abbott also pulled the drug in Canada and Australia today. Regulators removed Meridia from the [...]
FDA approves Botox as migraine preventive
Federal health authorities on Friday approved Botox injections for the prevention of chronic migraines in adults, an advance experts described as “modest.” In a statement, the Food and Drug Administration recommended Botox be injected approximately every three months around the head and neck to dull future headache symptoms. The drug — whose generic name is [...]
FDA Confirms September 16th Advisory Committee Meeting To Review Lorcaserin For Obesity And Weight Management
Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) and Eisai Inc. announced that the US Food and Drug Administration (FDA) has notified the company of the confirmed scheduling of an Endocrinologic and Metabolic Drugs Advisory Committee meeting on September 16, 2010, for the review of the lorcaserin New Drug Application (NDA). Lorcaserin, which Arena discovered and has developed [...]
Allergan’s Botox Migraine FDA Review Extended 3 Months
IAPAM News: Aug. 2 (Bloomberg) — Allergan Inc. said U.S. regulators extended by three months a review of its top product, the wrinkle-smoother Botox, for a new use as a migraine treatment. The U.S. Food and Drug Administration asked for information on safety monitoring of Botox as a migraine treatment and requested doctor training, the [...]
Merz Aesthetics™ Asclera™ (polidocanol) Injection Now Available in Doctors’ Offices Nationwide
Merz Aesthetics today announced it is now shipping Asclera™ (polidocanol) Injection sclerotherapy treatment to doctors’ offices throughout the U.S. Previously only available in Europe, Asclera™ was recently approved by the U.S. Food and Drug Administration (FDA). In a study published in the June issue of Phlebology, leading experts conclude that polidocanol is a highly effective [...]
FDA Agrees to UltraShape 510(k) Pathway – Expected to Shorten FDA Clearance Process
UltraShape Ltd. announced today that the US Food and Drug Administration advised the company that it may submit a request for clearance of its Contour I system under the 510(k) regulation rather than as a Pre-Market Approval (PMA) as was previously advised. Proceeding under the 510(k) pathway is expected to simplify and shorten the submission [...]
FDA approves adapalene lotion for acne
The Food and Drug Administration (FDA) has approved the lotion formulation of adapalene (Differin 0.1 percent, Galderma) for the topical treatment of acne in patients age 12 and older, Medscape Today reports.FDA approval was based on data from two 12-week, multicenter clinical trials of 2,141 patients with 20 to 50 inflammatory and 30 to 100 [...]
FDA Issues Warning Letters for Drugs Promoted in Fat Elimination Procedure
The U.S. Food and Drug Administration issued warning letters to six U.S. based medical spas and a company in Brazil for making false or misleading statements on their Web sites about drugs they claim will eliminate fat in a procedure called “lipodissolve,” or for otherwise misbranding lipodissolve products. The U.S. companies involved have made claims [...]
Mesa firm gets FDA approval on ultrasound device
A Mesa startup company has developed a medical device that uses ultrasound technology to treat everything from sagging eyebrows to liver cancer. Guided Therapy Systems of Mesa said the device allows doctors to see and treat tissue without using traditional surgery. The device will be used initially for cosmetic purposes, but backers say the technology [...]
Solta Medical Announces FDA 510(k) Clearance of New Fraxel re:store Dual Laser System
Solta Medical, Inc., recently announced it has received FDA 510(k) clearance for the new Fraxel re:store Dual laser system. The Fraxel re:store Dual system adds a novel 1927 nm wavelength, the first ever application of a Thulium laser in the aesthetics market, to the company’s existing technology. The new Fraxel re:store Dual system is optimized [...]
