Food / Drugs

Evolus Vows To Move Forward As FDA Fails To Approve Its Neurotoxin

Posted On: May 17, 2018   |   Posted By: Surgical Aesthetics Magazine

The approval of Evolus' DWP-450 has hit a snag, repotedly due to concerns at the Daewoong manufacturing facility slated to create the product. The U.S. Food & Drug Administration issued a complete response letter to the company's biologic license application for DWP-450 outlining concerns that must be addressed before the FDA can approve the new neurotoxin for marketing in the U.S.
In a call to investors and publicly released statement, the company did not elaborate on the FDA's concerns other than to note that the deficiencies cited related to Chemistry, Manufacturing, and Controls processes, not clinical performance of the product.
“We are pleased with the progress we continue to make with the FDA, and this CRL confirms our confidence in our clinical submission. Deficiencies cited within the CRL are isolated to CMC matters and we expect to respond comprehensively within 90 days,” said David Moatazedi, president and CEO of Evolus. “Overall, we view these updates as positive,...

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