Business & Investment

US FDA Refuses to Approve Reuters Revance’s Frowning Treatment

© Reuters. File Photo: The sign will be seen outside the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, USA, on August 29, 2020.Reuters / Andrew Kelly / File Photo

(Reuters)-Revance Therapeutics (NASDAQ :) Inc said on Friday that the U.S. Food and Drug Administration refused to approve a long-acting injection to treat moderate to severe frowns, causing stock prices to plummet by 29%. Told.

The company said the FDA pointed out “deficiencies” related to regulatory inspections at Revance’s manufacturing sites.

The drug developer said no other concerns were raised in the authorities’ “complete response letter.”

Revance Injectable Daxis Botulinum Toxin A, AbbVie Botox anti-wrinkle injection (NYSE :) succeeded in reducing moderate to severe frowning lines in a late December 2018 study.

Last November, the US FDA postponed the drug’s decision because the COVID-19 travel ban prevented it from conducting the necessary tests on its manufacturing facilities. Revance later said he was hoping for approval in 2021.

“We are very disappointed with this unexpected response from the FDA and are asking the FDA for further clarification,” Revance CEO Mark Foley said in a statement on Friday.

Revance said it would request a meeting with the FDA as soon as possible to address the FDA’s concerns.

The company’s stock, which closed at $ 22.71 on Friday, was $ 16.20 in an expansion transaction.

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US FDA Refuses to Approve Reuters Revance’s Frowning Treatment US FDA Refuses to Approve Reuters Revance’s Frowning Treatment

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