Posted by Michael Wonder on 25 May 2021
TherapeuticsMD announces submission of low dose Bijuva 0.5 mg/100 mg supplemental new drug application to FDA
25 May 2021 - TherapeuticsMD announced today that the Company submitted a supplemental new drug application for BIJUVA (oestradiol and progesterone) 0.5 mg - 100 mg capsules to the U.S. FDA.
The Company expects to learn of the acceptance of the supplemental new drug application upon receipt of the filing review notification from the FDA, approximately 74 days after submission. If accepted, the Company expects that the review time under the Prescription Drug User Fee Act will be within ten months of receipt by the FDA, approximately 21 March 2022.
