Posted by Michael Wonder on 08 May 2022
Myovant & Pfizer provide update on supplemental new drug application for Myfembree for the management of moderate to severe pain associated with endometriosis
6 May 2022 - Myovant Sciences & Pfizer announced today that the U.S. FDA has extended the review period for the supplemental New Drug pplication 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 requires extended time to review additional information the Agency requested from the companies regarding bone mineral density.
The extended Prescription Drug User Fee Act goal date is 6 August 2022.
