FDA Approves Palomar’s Anti-Wrinkle Device
June 17, 2009
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 could add between $12.5 million and $40.0 million to Palomar’s 2010 revenues.
Three analysts on average were expecting Palomar to post revenue of $89.5 million in 2010, according to Reuters Estimates.
The device was developed by Palomar and completed together with Johnson and Johnson Consumer Cos, under a previously announced deal to develop light-based anti-aging devices, the company said in a statement.
Palomar shares were up 58 percent at $17.35 in Friday afternoon trade on Nasdaq. They touched a high of $17.72 earlier in the session.
Maxim Group makes a market in Palomar and intends to seek investment banking business from the company within the next three months.
Source: Reuters
A new wrinkle for Botox users: Stronger warnings
May 6, 2009
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 injection, the Food and Drug Administration said. Read more
FDA Approves the latest Botulinum Toxin Type A: DYSPORT
May 1, 2009
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 pain, and the temporary improvement in the appearance of moderate to severe glabellar lines in adults younger than 65 years of age. Reloxin®, which was the proposed U.S. name for Ipsen’s botulinum toxin product for aesthetic use, will be marketed under the name of DYSPORT(TM). Ipsen will market DYSPORT(TM) in the United States for the therapeutic indication (cervical dystonia), while Medicis will market DYSPORT(TM) in the U.S. for the aesthetic indication (glabellar lines).
Additionally, DYSPORT(TM) is differentiated from other marketed botulinum toxin products with the unique established name abobotulinumtoxinA. Read more
FDA takes second critical look at topical anesthetics
February 24, 2009
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 have been in getting across its message regarding the use of topical anesthetics containing drugs such as lidocaine, tetracaine, benzocaine and prilocaine. Read more
SafeStitch Announces FDA Approval to Market Its SMART Dilator
February 18, 2009
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 complication for patients - in the approximately 2,000,000 esophageal dilations performed annually worldwide,” said Dr. Charles J. Filipi, SafeStitch’s Medical Director. Dr. Filipi added that, “the SMART Dilator is expected to simplify and shorten the dilation process, which will help endoscopic clinics operate more safely and efficiently.” Read more
FDA Extends Review of Reloxin until April 13, 2009
January 15, 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. Read more
FDA Approves LATISSE
December 29, 2008
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 and only science-based treatment approved by the FDA to enhance eyelash prominence as measured by increases in length, thickness and darkness of eyelashes. Read more
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
IAPAM Aesthetic Medicine Resources
Events & Webinars
Botox Dermal Filler Training- July 25-26, 2009
Event Date: July 25-26, 2009 Event Location: Toronto, Canada Presented by the International Association for Physicians in Aesthetic Medicine (IAPAM) presents the... Read more »
IAPAM Aesthetic Medicine Symposium - September 26-27, 2009
Event Date: September 26-27, 2009 Event Location: Scottsdale, Arizona Presented by the International Association for Physicians in Aesthetic Medicine (IAPAM), the... Read more »
IAPAM Aesthetic Practice Startup Workshop - September 28, 2009
Event Date: September 28, 2009 Event Location: Scottsdale, Arizona Presented by the IAPAM, the Aesthetic Practice Startup Workshop will prepare you for all the steps... Read more »
IAPAM Aesthetic Medicine Symposium - Oct 24-25, 2009
Event Date: October 24-25, 2009 Event Location: Scottsdale, Arizona Presented by the International Association for Physicians in Aesthetic Medicine (IAPAM), the... Read more »