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Company Name Myovant Sciences Ltd
MYOV
Drug Name MYFEMBREE (sNDA)
Event Name FDA decision on MYFEMBREE for management of moderate to severe pain associated with endometriosis.
Event Date 08/06/2022
Outcome Date 08/06/2022
Outcome FDA approved MYFEMBREE for management of moderate to severe pain associated with endometriosis on Aug.6, 2022
Drug Status Myovant and Pfizer are jointly commercializing MYFEMBREE
Rival Drugs AbbVie/Neurocrine Biosciences' ORIAHNN
Market Potential Launched in the U.S. in mid-June 2021, Myfembree generated net revenue of $4.1 million for Myovant Sciences in 2021
Other Approvals MYFEMBREE was approved by the FDA on on May 26, 2021 for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women
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