Myovant Sciences and Pfizer announce FDA acceptance of supplemental new drug application for Myfembree for the management of moderate to severe pain associated with endometriosis

Myovant Sciences

9 September 2021 - FDA PDUFA target action date is 6 May 2022.

Myovant Sciences and Pfizer today announced that the U.S. FDA accepted for review a 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.

Read Myovant Sciences press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier