WEDNESDAY, September 11, 2013 — The U.S. Food and Drug Administration today approved a new use for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe lateral canthal lines, known as crow’s feet, in adults. Botox Cosmetic is the only FDA approved drug treatment option for lateral canthal lines.

The FDA approved Botox Cosmetic in 2002 for the temporary improvement of glabellar lines (wrinkles between the eyebrows, known as frown lines), in adults. Botox Cosmetic works by keeping muscles from tightening so wrinkles are less prominent

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BOTOX Cosmetic (onabotulinum toxin A) For Injection, is a sterile, vacuum-dried purifiedbotulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinumtype A grown in a medium containing casein hydrolysate, glucose, and yeast extract, intended for intramuscular use. It is purified from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing Albumin Human and is sterile filtered (0.2 microns) prior to filling and vacuum-drying.

The primary release procedure for BOTOX Cosmetic uses a cell-based potency assay to determine the potency relative to a reference standard. The assay is specific to Allergan’s products BOTOX and BOTOX Cosmetic. One Unit of BOTOX Cosmetic corresponds to the calculated median intraperitoneal lethal dose (LD50) in mice. Due to specific details of this assay such as the vehicle, dilution scheme and laboratory protocols, Units of biological activity of BOTOX Cosmetic cannot be compared to nor converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method. The specific activity of BOTOX Cosmetic is approximately 20 Units/nanogram of neurotoxin protein complex.

Each vial of BOTOX Cosmetic contains either 50 Units of Clostridium botulinum type A neurotoxin complex, 0.25 mg of Albumin Human, and 0.45 mg of sodium chloride; or 100 Units of Clostridium botulinum type A neurotoxin complex, 0.5 mg of Albumin Human, and 0.9 mg of sodium chloride in a sterile, vacuum-dried form without a preservative.

Since the approval of BOTOX^® Cosmetic by the U.S. Food and Drug Administration in 2002, Allergan has virtually changed the face of medical aesthetics. Men and women between the ages of 18 to 65 now have the ability to choose science-based, non-invasive medical aesthetic solutions, including BOTOX^® Cosmetic and the JUVÉDERM^® family of dermal fillers, to achieve their own results. Over the last seven years, there have been nearly 11.8 million BOTOX^® Cosmetic treatments recorded in the United States.¹ More importantly, its 97 percent satisfaction rating (survey of 117 patients)^2,3 is just one indication of the trust consumers have placed in Allergan.

BOTOX^® Cosmetic is a simple, non-surgical procedure for temporarily reducing the appearance of moderate to severe glabellar lines – the vertical frown lines between the eyebrows that look like an “11” – in adult women and men aged 18 to 65. BOTOX^® Cosmetic reduces the activity of the muscles that cause the “11s” to form by blocking nerve impulses that trigger wrinkle-causing muscle contractions, creating an improved appearance between the brows. Results can last up to four months and may vary with each patient. Ask your doctor if BOTOX^® Cosmetic is right for you.