FDA News
FDA Approves LATISSE
New Prescription Product Increases Length, Thickness and Darkness of Eyelashes Allergan, Inc. (NYSE: AGN) today announced the U.S. Food and Drug Administration (FDA) has approved LATISSE(TM) (bimatoprost ophthalmic solution) 0.03% as a novel treatment for hypotrichosis of the eyelashes. Eyelash hypotrichosis is another name for having inadequate or not enough eyelashes. LATISSE(TM) is the first […]
FDA Wants Stronger Warning for Dermal Fillers
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 […]
FDA Calls Meeting on Dermal Fillers
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 […]
Artes Medical Announces Completion of Enrollment in 1,000 Patient Post-Marketing ArteFill Study
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.
Radiofrequency device for skin treatment wins FDA approval
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.
FDA postpones review of botulinum toxin type A, Dysport
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.
Allergan Announces Positive Top-Line Results from Phase III BOTOX Headache Program
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 […]
Alma Lasers Announces FDA Clearance of the Pixel CO2 OMNIFIT Handpiece
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 […]
PEAK Surgical Receives 510(k) Clearance to Market PEAK® Surgery System for Use in General Surgery
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 […]
FDA Approves EVOLENCE, a New Generation Collagen-Based Facial Filler
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 […]
