Posted by Michael Wonder on 12 Apr 2022
Myovant Sciences and Pfizer provide update on supplemental new drug application for Myfembree for the management of moderate to severe pain associated with endometriosis
12 April 2022 - Myovant Sciences and Pfizer announced today an update on the Supplemental new drug application for Myfembree (relugolix 40 mg, estradiol 1 mg and norethindrone acetate 0.5 mg) for the management of moderate to severe pain associated with endometriosis.
In accordance with the ongoing review of the application, on 6 April 2022, the U.S. FDA provided notice to the companies that the agency identified deficiencies that preclude discussion of labelling and/or post-marketing requirements and commitments at this time.
