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

TherapeuticsMD Inc 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.