FDA warns Allergan about Latisse claims
This article was originally published in The Rose Sheet
Executive SummaryFDA'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...
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 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.