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FDA DODAC Approves Eyelash Drug
Posted: December 22, 2008
Allergan Inc. has announced that the U.S. Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) voted unanimously (9-0) to recommend that the FDA approve Latisse (bimatoprost solution 0.03%) as a treatment for hypotrichosis or reduced amount of hair of the eyelashes.
The drug is a spinoff of the glaucoma drug Lumigan. In treating glaucoma, consumers noticed longer, darker and thicker eyelashes as a side effect of their treatment.
If approved, Latisse would be the first and only FDA-approved pharmaceutical to enhance eyelash prominence. 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.
In addition to its unanimous recommendation for approval of Latisse, the Committee also voted 5-3 (1 abstained vote) in favor of Phase 4 (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.