FDAnews Drug Daily Bulletin

FDA Approves New Formulation of Valeant’s Retin-A

Feb. 3, 2014

The FDA has approved Valeant Pharmaceuticals’ sNDA for Retin-A Micro Gel Microspheres 0.08 percent, the Québecois drugmaker said Friday.

Retin-A (tretinoin) is a form a vitamin A that is applied to the skin topically and is available commercially in cosmetic creams that treat acne. Valeant plans on launching the microspheres in the U.S. later this year.

The drugmaker, meanwhile, recently submitted NDAs for two anti-fungal products, with a third completing Phase III and a fourth just beginning Phase III for psoriasis. One such application, for Jublia (efinaconazole), a treatment for the nail fungus onychomycosis, received a complete response letter from the FDA in May 2013. No efficacy or safety issues were raised by the FDA, Valeant said at the time, noting the issue centered specifically on a container closure system.

“We have since met with the FDA to discuss their concerns and believe there is potential for approval in the second or third quarter of 2014,” the company said. — Lena Freund

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