U.S. FDA extends review of Pfizer and Myovant Sciences supplemental New Drug Application (sNDA) For MYFEMBREE by three months

The U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) from Pfizer Inc. (NYSE:PFE) and its partner Myovant Sciences (NYSE:MYOV) 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 regulatory agency has set a new goal date of August 6, 2022.