FDA Wants Stronger Warning for Dermal Fillers
November 20, 2008
Product labels on popular cosmetic wrinkle fillers should be strengthened to warn consumers about scarring and other problems that can crop up weeks or years after receiving the treatments, a Food and Drug Administration panel said November 18, 2008.
The panel said current product labels on fillers approved to plump certain facial lines are inadequate and only discuss immediate and temporary side effects, such as swelling. While an FDA review of reported adverse events associated with dermal fillers showed many expected side effects like temporary swelling and redness, the agency said “there are a number of adverse events that are serious and unexpected.” Read more
FDA Calls Meeting on Dermal Fillers
October 22, 2008
The FDA last week announced a public meeting to be held in November by the Committee General and Plastic Surgery Devices Panel, to review numerous issues surrounding dermal fillers.
On November 18, 2008, the FDA will receive an update on safety information collected on dermal fillers in the commercial setting, discuss current premarket and postmarket approved study designs, and make recommendations on general issues concerning the study of various dermal fillers. Read more
Artes Medical Announces Completion of Enrollment in 1,000 Patient Post-Marketing ArteFill Study
October 21, 2008
Artes Medical, Inc. (Nasdaq:ARTE), a medical aesthetics company, today announced that enrollment has been completed in the 1,000-patient post-marketing study required by the FDA. The study follows patients treated with ArteFill(R), the first and only FDA-approved non-resorbable dermal filler, for a five-year period. Read more
Radiofrequency device for skin treatment wins FDA approval
October 8, 2008
Syneron Medical Ltd., based here, has received U.S. Food and Drug Administration (FDA) approval for its Matrix RF applicator for use in dermatological procedures requiring skin ablation and resurfacing, CNNMoney.com reports.
Syneron had received CE mark clearance in Europe shortly before the FDA announced its approval of the Matrix RF. Read more
FDA postpones review of botulinum toxin type A, Dysport
October 8, 2008
French pharmaceutical company Ipsen says the U.S. Food and Drug Administration (FDA) will not complete its first-cycle review of Ipsen’s botulinum toxin type A product Dysport until the end of the year, Reuters reports. Read more
Allergan Announces Positive Top-Line Results from Phase III BOTOX Headache Program
September 12, 2008
Phase III Studies Show Statistically Significant Decrease in Number of Headache Days –
IRVINE, Calif., Sep 11, 2008 (BUSINESS WIRE) — Allergan, Inc. (NYSE: AGN) today announced that it has completed a top-line analysis of its two Phase III clinical trials exploring the use of BOTOX(R) (botulinum toxin type A) for the prophylactic treatment of headache in adults suffering from chronic migraine — i.e., headaches and/or migraines that occur on 15 or more days each month. Read more
Alma Lasers Announces FDA Clearance of the Pixel CO2 OMNIFIT Handpiece
August 8, 2008
New high-tech handpiece gives physicians’ practices a face lift
CHICAGO, Aug 05, 2008 /PRNewswire via COMTEX/ — Alma Lasers Ltd. (”Alma”), a leader in laser, light, and radiofrequency-based aesthetic devices, announced today the FDA clearance and immediate availability of the Pixel CO2 OMNIFIT handpiece at The American Academy of Dermatology Summer Meeting in Chicago. The Pixel CO2 OMNIFIT is Alma’s newest offering in skin rejuvenation and it is an upgrade to physicians’ existing CO2 skin resurfacing lasers. It is designed to provide patients with impressive results with just a fraction of the downtime compared to current treatments, and for significantly less money than replacing their current laser. Read more
PEAK Surgical Receives 510(k) Clearance to Market PEAK® Surgery System for Use in General Surgery
July 25, 2008
PALO ALTO, Calif. (July 24, 2008) - PEAK Surgical, Inc., a medical device company that has developed a new tissue dissection system based on a proprietary technology, today announced that the U.S. Food and Drug Administration has granted the company 510(k) clearance to market its PEAK® Surgery System for use in general surgery. The PEAK Surgery System combines the PULSARTM Generator, which supplies pulsed plasma radiofrequency energy, with the PEAK PlasmaBladeTM 4.0, a low-temperature surgical cutting and coagulation tool. This tissue dissection system will be commercially available next month. Read more
FDA Approves EVOLENCE, a New Generation Collagen-Based Facial Filler
July 2, 2008
The U.S. Food and Drug Administration (FDA) today announced the approval of EVOLENCE® for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds. EVOLENCE® is a new advanced collagen-based structural dermal filler, and a first of its kind product. The introduction of EVOLENCE® marks the first dermal filler entry for the Aesthetics Group of OrthoNeutrogena. While new to the United States, EVOLENCE® has been available in other markets such as in Canada, Western and Eastern Europe, Israel, South Korea and Russia since 2004. Read more
Allergan Announces Intent to File New Drug Application for Bimatoprost as Novel Treatment to Stimulate Natural Eyelash Growth
June 4, 2008
Allergan, Inc. announced today that it intends to file a New Drug Application for bimatoprost, a synthetic prostaglandin analog, as a treatment to stimulate eyelash growth. Allergan has completed its clinical trial program demonstrating that its patented formulation of bimatoprost, when applied directly to the base of the eyelashes, results in significant eyelash growth. Read more
IAPAM Aesthetic Medicine Resources
