FDA accepts NDA for Myfembree for severe pain associated with Endometriosis
Myovant Sciences and Pfizer Inc announced that the U.S. Food and Drug Administration (FDA) accepted for review a supplemental New Drug Application (sNDA) 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. The FDA set a target action date of May 6, 2022 for this sNDA under the Prescription Drug User Fee Act (PDUFA).