Posted by Michael Wonder on 04 Feb 2020
TherapeuticsMD announces submission of new drug application prior approval efficacy supplement to the U.S. FDA for lower dose of Bijuva
3 February 2020 - TherapeuticsMD announced today that it submitted a new drug application prior-approval efficacy supplement for Bijuva 0.5 mg/100 mg (estradiol and progesterone) capsules to the U.S. FDA late January 2020.
The submission includes data from the Company’s Phase 3 Replenish Trial for Bijuva for which the Company announced results in December 2016, together with additional information and analyses. The Company expects to learn of the acceptance of the efficacy supplement upon receipt of the Filing Review Notification from the FDA, approximately 74 days after the submission of the NDA efficacy supplement.
If accepted for review by the FDA, the Company expects that the NDA efficacy supplement will be reviewed under current Prescription Drug User Fee Act timeline goals, within ten months of receipt by the FDA.
