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ATX-101 receives unanimous support for FDA approval

Article-ATX-101 receives unanimous support for FDA approval

Kythera Biopharmaceuticals announced in a press release dated March 9, 2015, that the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee unanimously voted in support of ATX-101 approval for injectable submental contouring.

This independent panel of experts met yesterday to discuss ATX-101 and offered their recommendation to the FDA, which will be considered during continued review of the product. The FDA typically accepts the panel's recommendations. If it is approved, Kythera plans to launch ATX-101 during the second half of this year, according to the release. 

Related: ATX-101 will create a new market in facial aesthetics if approved

“We look forward to working with the FDA as they continue their review of ATX-101 with the goal of providing patients with the first and only approved non-surgical treatment for submental fullness,” said Frederick Beddingfield, III, M.D., Ph.D., chief medical officer of Kythera.  

The FDA is scheduled to make its final decision by May 13.

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