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TherapeuticsMD's Birth Control Med Receives FDA Response Letter To Revise Manufacturing Testing Limits

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  • TherapeuticsMD Inc (NASDAQ: TXMD) said that the FDA could not approve revisions to certain manufacturing testing limits for Annovera through the supplemental marketing application previously submitted by the Company.

  • The supplemental application requested minor revisions to the in vitro release testing specification for Annovera to allow for normal commercial manufacturing variation.

  • Also, see Benzinga's Full FDA Calendar here.

  • The Company submitted the proposed revisions to the manufacturing testing limits to efficiently and quickly increase supply to meet anticipated patient demand for Annovera.

  • The FDA provided recommendations and requested additional information to revise certain manufacturing testing limits in its complete response letter.

  • The Company will continue manufacturing and supplying Annovera under the existing approved specifications.

  • Annovera, approved in August 2018 by FDA, is the only long-lasting, reversible, procedure-free birth control, the Company said.

  • Related Link: TherapeuticsMD, Amneal Settle US Patent Litigation For Bijuva.

  • Price Action: TXMD shares traded 18.6% lower at $0.37 during premarket trading on the last check Monday.

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