FDA News
Coapt Systems, Inc. Launches Hydrelle(TM) a New, FDA-Approved Dermal Filler with Lidocaine for Significant Wrinkle Correction and Greater Patient Comfort
The first FDA-approved injectable dermal filler to combine hyaluronic acid and lidocaine, a local anesthetic that improves patient comfort, and provides physicians with a new alternative for their aesthetic practice. Designed, developed and manufactured by Anika Therapeutics, hydrelle is formulated for durability based on its proprietary cross-linking technology and the highest concentration of hyaluronic acid. […]
Information for Healthcare Professionals: Botox/Botox Cosmetic, Dysport and Myobloc
FDA ALERT [08/2009]: As announced on April 30, 2009, based on a safety evaluation of the botulinum toxin products, FDA has concluded that the prescribing information for OnabotulinumtoxinA (marketed as Botox/Botox Cosmetic) and RimabotulinumtoxinB (marketed as Myobloc) must be updated to ensure their continued safe use. On July 31, 2009, FDA, under the authorities granted […]
FDA Approves Sculptra® Aesthetic, a Facial Injectable for Correction of Nasolabial Folds and Other Facial Wrinkles
BRIDGEWATER, N.J., July 29 /PRNewswire-FirstCall/ — Sanofi-aventis U.S. announced that the U.S. Food and Drug Administration (FDA) approved Sculptra® Aesthetic (injectable poly-L-lactic acid) for the correction of shallow to deep nasolabial fold (smile lines) contour deficiencies and other facial wrinkles which are treated with the appropriate injection technique in healthy patients. Sculptra® Aesthetic works gradually […]
BioForm Medical Receives FDA Approval for Mixing Lidocaine With RADIESSE® Dermal Filler
BioForm Medical, Inc. (Nasdaq:BFRM) announced U.S. Food and Drug Administration (FDA) approval for a method of mixing RADIESSE® dermal filler with lidocaine, which, in clinical trials, has demonstrated an improvement in patient comfort and an increase in patient satisfaction with RADIESSE dermal filler procedures. BioForm Medical will immediately begin commercial efforts to educate physicians to […]
FDA Approves Palomar’s Anti-Wrinkle Device
Palomar Medical Technologies Inc (PMTI.O) said U.S. health regulators approved over-the-counter (OTC) marketing of its laser device for treatment of wrinkles around the eyes, sending the aesthetic device maker’s shares up as much as 60 percent. “It’s a major positive. It’s a huge market opportunity,” Maxim Group analyst Anthony Vendetti said. He estimated the device […]
A new wrinkle for Botox users: Stronger warnings
Allergan Inc. was ordered by U.S. regulators to strengthen precautions on its wrinkle smoother Botox, hours after the first major competition to the treatment, Dysport, was approved for sale. Botulinum toxins used to relax forehead lines and treat neurological disorders may cause muscle weakness or breathing difficulties if the poison spreads beyond the site of […]
FDA Approves the latest Botulinum Toxin Type A: DYSPORT
Medicis (NYSE:MRX) and Ipsen (Euronext:IPN) announced the U.S. Food and Drug Administration’s (FDA) approval of the Biologics License Application (BLA) for DYSPORT(TM) (abobotulinumtoxinA), an acetylcholine release inhibitor and a neuromuscular blocking agent. The approval includes two separate indications, the treatment of cervical dystonia in adults to reduce the severity of abnormal head position and neck […]
FDA takes second critical look at topical anesthetics
WASHINGTON — The results of a recent study has prompted the FDA to issue its second warning in two years about the potential dangers of using topical anesthetics for pain relief from medical tests and conditions. The most recent warning also begs the question of whether the first advisory was as effective as it might […]
SafeStitch Announces FDA Approval to Market Its SMART Dilator
SafeStitch Medical, Inc. (OTCBB:SFES) announced that the U.S. Food and Drug Administration (“FDA”) has approved the Company’s 510(k) application to begin U.S. marketing of its SMART DilatorTM, the first esophageal dilator to indicate the pressure level being applied at the esophageal stricture. “Having this information should reduce the incidence of esophageal perforation – a devastating […]
FDA Extends Review of Reloxin until April 13, 2009
Ipsen today announced that the U.S. Food and Drug Administration (FDA) provided notification that the Prescription Drug User Fee Act (PDUFA) action date for Reloxin® (botulinum toxin of type A) Biologics License Application (BLA) in aesthetic indications (glabellar lines) has been extended to April 13, 2009.
