| |
|
What is a VISTABEL®?
"VISTABEL®" is the name that Allergan has chosen to market BOTOX® cosmetic in France. The followintg is a press release regarding BOTOX® cosmetic being approved in France as "VISTABEL®".
Allergan's Botox Product Receives Approval in France for the Treatment of Glabellar Lines -Brow Furrow- Tuesday February 25, 3:05 am ET
New Cosmetic Indication will be Marketed in France as VISTABEL(R)
IRVINE, Calif.--(BUSINESS WIRE)--Feb. 25, 2003-- Allergan, Inc. (NYSE:AGN - News) today announced that its BOTOX® (botulinum toxin type A) product has received the first approval in France by the Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) for this type of product to treat glabellar lines. In conjunction with this approval, BOTOX® will be marketed in France for this use under the name VISTABEL®. France will act as the Reference Member State in the mutual recognition process for this indication within the European Union. This newly approved indication is now licensed for use in 19 countries including the United States, Canada, Australia, New Zealand and Switzerland.
Glabellar lines are vertical frown lines that occur between the eyebrows, which are formed by excessive contractions of two of the major muscles in the forehead, the corrugator and procerus muscles. Continued excessive contraction of these two muscles can leave one with a stressed or angry-looking appearance, even when that emotion is not felt. BOTOX® COSMETIC/VISTABEL® works to relax these muscles by blocking nerve impulses that trigger wrinkle-causing muscle contractions, smoothing and improving the appearance of the frown lines between the brow. Administered in a few tiny injections of purified protein, this minimally invasive treatment is simple and quick and delivers dramatic results with minimal discomfort. Results can be seen as early as 24-48 hours and the effect lasts up to four months.
"We are extremely pleased to have received this approval in France for VISTABEL®. This marks a significant step toward increasing the number of approvals worldwide for this use and we hope to receive additional approvals in 2003 throughout Europe," said Lester J. Kaplan, Ph.D., Allergan's President of Research and Development and Global BOTOX®. "We believe strongly in the safety and effectiveness of the BOTOX® product and are excited to be able to offer this treatment to consumers in France."
The safety of BOTOX® COSMETIC / VISTABEL® as a treatment for wrinkles has been proven in multiple clinical studies. In a 12-month repeated treatment study in the U.S. and Canada, the four-month double-blind, placebo-controlled period that evaluated the efficacy of BOTOX® COSMETIC / VISTABEL® showed that 80% of those patients treated with BOTOX® Cosmetic experienced maximum effect after 30 days. After two additional injections, maximum reduction of glabellar lines was achieved with 89% of the patients.
Treatment with BOTOX® COSMETIC / VISTABEL® should be administered in a medically appropriate setting by a qualified and aesthetic-specialty physician with an in-depth knowledge of facial anatomy.
BOTOX® COSMETIC / VISTABEL® is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any ingredient in the formulation. The most common side effects, if any occur, may include headache, respiratory infection, flu syndrome, temporary eyelid droop and nausea. Full prescribing information for BOTOX® Cosmetic in the United States is available at www.botoxcosmetic.com.
Allergan's BOTOX® product carries the unique distinction of being the only product of its kind with over 20 years experience in clinical development and 14 years as a successfully marketed product that has been used in over a million people worldwide. It is currently approved in over 70 countries providing significant clinical benefits for previously untreated disorders in a broad range of neurological and aesthetic conditions including cervical dystonia, juvenile cerebral palsy, strabismus (crossed eyes), blepharospasm (uncontrollable blinking), post-stroke spasticity, hemifacial spasm, hyperhidrosis and glabellar lines. BOTOX® for aesthetic use is marketed as BOTOX® / BOTOX® COSMETIC / or VISTABEL® depending on the country of approval. "
Learn how the BOTOX treatment using a BOTOX® shot works. |
