Botox approval
This article was originally published in The Rose Sheet
Executive Summary
Allergan will market prescription drug Botox Cosmetic with $40 mil.-$50 mil. ad campaign following FDA approval April 15, Irvine, Calif. company says. Botulinum Toxin Type A, already widely used in cosmetic surgery, was formally approved by the agency for cosmetic use to "to temporarily improve the appearance of moderate to severe frown lines between the eyebrows," FDA announces. When injected into skin in small doses, the toxin paralyzes or weakens the muscle, FDA says, noting the majority of investigators and 405 patients evaluated in placebo-controlled, multi-center randomized clinical trials noticed an improvement in lines when injected with Botox. More than 850,000 people had Botox injections in 2001, according to American Society of Plastic Surgeons...
You may also be interested in...
Botox Cosmetic ads cited by FDA
Allergan's Botox Cosmetic (botulinum toxin A) "WOW" TV reminder ad discloses anti-wrinkle agent's indication by discussing age, focusing on complexion and image and directing consumer to a dermatologist or plastic surgeon, FDA says in a Sept. 5 letter to firm, requesting ads be discontinued. Under FDA rules, reminder ads need not include a full summary of side effects as long as the product's use is not disclosed. However, Allergan's ad "strongly suggest[s] that the product is intended to treat the signs of aging or glabellar lines," FDA says and should therefore be revised and submitted to the agency for review prior to airing. In a statement Sept. 12, Allergan said it plans to respond to FDA's concerns by Sept. 16. Botox was approved in April (1"The Rose Sheet" April 22, 2002, In Brief)...
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.