HBW Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA warns Allergan about Latisse claims

This article was originally published in The Rose Sheet

Executive Summary

FDA's Division of Drug Marketing, Advertising and Communications warned Allergan regarding misleading Web site claims for its Latisse (bimatoprost opthalmic solution) 0.03% eyelash enhancer because the claims "omit and minimize risks" associated with use of the product. The warning was made in a letter dated Sept. 10. Specifically, the pharmaceutical giant failed to communicate that some people are at risk of developing bacterial keratitis, which can be blinding, and that the drug can cause hair to grow in areas other than the eye upon repeated exposure, the agency notes. Based on a drug developed by the company to treat glaucoma, Latisse was approved by FDA in December 2008 as a treatment for "inadequate" eyelashes (1"The Rose Sheet" Jan. 5, 2009). Allergan was advised to respond to the letter by Sept. 24

You may also be interested in...



FDA approves Allergan eyelash enhancer

Pharmaceutical giant Allergan expects to launch its bimatoprost-based Latisse drug for treating "inadequate" eyelashes (hypotrichosis) in first quarter of 2009. A once-daily prescription treatment applied to the base of the upper eyelashes, "Latisse fulfills a significant and previously unmet need in the medical aesthetic marketplace with a product approved by the FDA that increases the growth of eyelashes, making them longer, thicker and darker," according to Allergan. Results are evident in eight to 16 weeks, firm says, but notes that to maintain luxurious lashes individuals must use the product on a continuing basis, a disclosure recommended by an FDA advisory committee in December (1"The Rose Sheet" Dec. 15, 2008, p. 7). Latisse could bring in $500 million in annual sales, the company says. Like Allergan's blockbuster botulinum toxin type A (Botox) drug, bimatoprost was first approved by FDA as a medical treatment - for patients with glaucoma, among other eye disorders - before its aesthetic benefits were realized. The 13+ years of clinical data supporting bimatoprost could heighten its advantage over eyelash enhancers on the cosmetics market, which sector has been vigilantly policed by Allergan in defense of its patents (2"The Rose Sheet" Jan. 14, 2008, p. 8)

Rising Costs, Price Pressure Usher In Uncertain Year Of The Rat In China

Once the world's factory, China has seen costs inch up while drug prices are being cut deeply by centralized procurement schemes. As uncertainties mount, companies need to focus on improving process and scale-up technology, suggested industry observers at a JPM panel discussion on innovation and market access challenges.

Biocon-Mylan's Plans For Broader US Fulphila Access, Glargine On Track

Biocon-Mylan press ahead with plans to broaden patient access in the US to biosimilar pegfilgrastim and are enthused with the initial uptake for their trastuzumab biosimilar ahead of more upcoming competition. A mid-2020 US launch for partnered insulin glargine is also on course.

UsernamePublicRestriction

Register

RS016425

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel