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news.Allergan, a multi-specialty healthcare company, has announced that the FDA Dermatologic and Ophthalmic Drugs Advisory Committee voted unanimously to recommend that the FDA approve Latisse as a treatment for hypotrichosis of the eyelashes.
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If approved, Latisse would be the first and only FDA-approved pharmaceutical to enhance eyelash prominence, the company said.
In addition to its unanimous recommendation for approval of Latisse, the committee also voted 5-3 (one abstained vote) in favor of Phase IV (post-market studies) to assess use in certain patient populations, including patients of younger age and post-chemotherapy patients with loss of eyelashes.
The committee’s recommendation, although not binding, will be considered by the FDA as it contemplates approval for Latisse as a treatment for eyelash growth. If approved by the FDA, Allergan anticipates launching Latisse in 2009.
Scott Whitcup, Allergan’s executive vice president of R&D, said: Today’s advisory committee recommendation is an important step in the FDA review process to provide consumers with a safe and effective treatment to improve the length, thickness and darkness of natural eyelashes.
If approved, Latisse will offer consumers an FDA-approved product which has been extensively studied in well-controlled clinical trials, is manufactured to pharmaceutical standards, is appropriately labeled for use, and is regulated as a prescription product.