FDA News
New Sunscreen Rules from FDA
Sunscreen labels will carry a “broad spectrum” label to show they offer some protection against UVA radiation as well as UVB radiation, according to a long-awaited new rule from the FDA. The old “SPF” designation still will show how well a product protects against UVB, although the highest SPF level a product can claim will […]
FDA Panel Backs Approval of Restylane for Lip Augmentation
Dermatologists may not have to use Restylane off label for lip augmentation any longer. On April 27, a Food and Drug Administration panel voted 6-0 with 1 abstention that benefits outweigh risks for using the filler as a submucosal injection for lip augmentation. The panel also voted 6-0 with 1 abstention that the filler is […]
Cutera gets FDA nod for device to treat fungal nails
Cutera Inc , which makes lasers for medical and aesthetic use, said U.S. health regulators approved its device to treat fungal nail infections, sending its shares up 6 percent in extended trade. Cutera’s GenesisPlus laser will now be used by physicians to treat nail fungus that often causes the toenails to become discolored, thickened and […]
[Homeopathic] hCG weight-loss products are fraudulent, FDA says
A popular type of weight-loss products, heavily promoted on the Internet, is fraudulent and illegal, Food and Drug Administration officials say. HCG weight-loss products that promise dramatic results and claim to be homeopathic are sold as drops, pellets and sprays on the Web, in drugstores and at General Nutrition Centers. They are supposed to be […]
FDA Says No — At Least for Now — to Arena’s Weight-Loss Pill – lorcaserin
Arena Pharmaceuticals said early Saturday morning that the FDA won’t approve the company’s weight-loss drug lorcaserin without further data to support the drug’s efficacy and safety. That wasn’t a terribly big surprise, given that an outside FDA advisory panel last month voted not to recommend approval. The FDA has questions about the possibility of a […]
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 […]
