FDA extends PDUFA date for Myfembree to manage moderate to severe pain associated with endometriosis . Myovant Sciences + Pfizer
Myovant Sciences and Pfizer Inc. announced that the FDA has extended the review period for the 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 requires extended time to review additional information the Agency requested from the companies regarding bone mineral density. The extended Prescription Drug User Fee Act (PDUFA) goal date is 6 August 2022.
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