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Allergan Celebrates 20 Years of Approved Use of Botulinum Toxin Type A (BOTOX(R)) in Canada

Twenty years ago, the first approved use of BOTOX(R) (botulinum toxin type A), a neurotoxin widely used to treat several life altering medical conditions, was granted in Canada. As part of the 20th anniversary celebrations, healthcare professionals from coast to coast reflect upon the discovery, science and evolution of a therapy that has impacted the lives of millions of patients worldwide.

BOTOX(R), a purified protein derived from the naturally-occurring bacterium Clostridium botulinum, was first approved by Health Canada on March 14th,1990 for the treatment of strabismus (crossed eyes), blepharospasm (uncontrollable blinking), and VII nerve disorder.(1) Other approvals for the medical uses of BOTOX(R) soon followed and included:

–  To reduce the subjective symptoms and objective signs of cervical
    dystonia (muscle contractions in the neck) on March 29th, 1995;
–  For the treatment of dynamic equinus foot deformity due to spasticity in
    pediatric cerebral palsy in patients two years of age or older on July
    7th, 1999;
–  For the treatment of hyperhidrosis of the axilla (excessive underarm
    sweating) on August 31st, 2001; and
–  In the management of focal spasticity (muscle tightness that can affect
    multiple areas of the body) on October 24th, 2001.(1) Read more

               

Opponents of Botox Tax Go Big: Baby Boomers! Women!

The Senate  health care bill’s 5% tax on elective cosmetic procedures (breast implants, Botox wrinkle treatments, etc.) is drawing opposition from predictable quarters: Cosmetic surgeons and companies that sell products used in cosmetic procedures.Allergan, which sells Botox, took a civil rights angle: The tax “discriminates against women,” the company said in a statement. Some 86% of cosmetic surgery patients are working women ages 35-50, with an average annual income of $55,000 per year, according to Allergan.

“What’s next? Are we going to tax people who color their hair?” the CEO of Medicis, a drug company that sells fillers, told Dow Jones Newswires. Read more

               

Pharma bracing for tougher FDA guidance on trials

Transparency welcomed, but threat of added costs creates concerns.

Pharmaceutical companies in New Jersey and elsewhere face more stringent requirements from the Food and Drug Administration on disclosures of mishaps in clinical trials.

And while industry groups and advisers have broadly welcomed the increased transparency and the move toward safer drugs, they want these actions to strike a balance with the costs of complying with them.

As of Sept. 27, the FDA requires drug manufacturers to include the general public in disclosures on “adverse” and “serious adverse” events beyond the regulator and patients participating in trials, said Satish Tadikonda, president of Virtify Inc., in Cambridge, Mass., which provides compliance services to life sciences companies.

Adverse events are side effects like rashes or headaches, while serious adverse events are those that result in death, disability or life-threatening situations, among others, Tadikonda said. Read more

               

Drug Maker Sues FDA Over Ban on Offering Doctors Info About Off-Label Uses

The makers of Botox filed a lawsuit last week against the FDA, challenging federal regulations that ban drug companies from marketing drugs for uses that they have not been established as safe and effective through the FDA approval process.

Allergan Inc. filed the complaint Thursday in the U.S. District Court in Washington, D.C., saying that the FDA’s ban on “off-label” drug promotion by pharmaceutical companies violates their first amendment rights to free speech. The ban restricts Allergan from offering information about off-label use of Botox, an antiwrinkle drug that is used by many doctors for unapproved uses, such as treatment of muscle spaticity in children with cerebral palsy.

Although doctors are allowed to prescribe medications for non-approved uses, drug makers are prohibited from marketing those applications. Allergan says that the ban is unconstitutional and prevents them from offering truthful information and other data that could help doctors prescribe the drugs effectively and safely. Read more

               

New developments in Botox

Kohala Coast, HI — When giving botulinum toxin type A (Botox, Allergan) to patients, dermatologists should tell them that it “relaxes the muscles temporarily. Let’s not say ‘paralyze’,” said Susan Weinkle, M.D., at the Winter Clinical Dermatology Conference.After offering that tip, which she said will relax patients and make them feel more comfortable about the procedure, Dr. Weinkle highlighted the pharmacology of Botox and how thought about its stability has changed throughout the years. Read more

               

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 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

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

               

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 headache in adults suffering from chronic migraine — i.e., headaches and/or migraines that occur on 15 or more days each month. Read more

               

Allergan says Botox works on chronic migraines

CHICAGO (Reuters) - Allergan Inc said on Thursday that its popular Botox wrinkle-smoother worked as a treatment for adults suffering from chronic migraines, according to late-stage clinical data.

Shares of Allergan rose nearly 13 percent as the broad market stumbled.

Botox, or botulinum toxin type A, is the first therapy being investigated for chronic migraine, which affects an estimated 1.2 million to 3.6 million people in the United States, according to the company. Read more

               

Novare Announces Successful Series of Single Port Lap Band Procedures with RealHand High Dexterity instruments

Dr. Julio Teixeira, Chief, Division of Minimally Invasive Surgery at St. Luke’s-Roosevelt Hospital Center completes his 12th Single Port Lap-Band® Procedure; Bariatric patients now benefiting from ‘hidden scar’ procedure.

Novare Surgical Systems announced the successful completion of a series of single port Lap-Band procedures that results in reduced scarring and less postoperative pain for patients. Dr. Julio Teixeira at St. Luke’s-Roosevelt Hospital in NY has pioneered an innovative approach that allows for the entire Lap-Band procedure to be performed exclusively through the patient’s belly button and he is believed to be the first surgeon to successfully do so. Dr. Teixeira uses RealHand HD instruments to enable the procedure and his approach eliminates an upper abdominal trocar placement that is often a site for significant patient discomfort. Read more

               

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