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Myovant : FDA Identifies 'deficiencies' In SNDA Review Of Myfembree On Endometriosis-related Pain

Myovant Sciences (MYOV) and Pfizer (PFE), in an update on supplemental new drug application for myfembree for the management of moderate to severe pain associated with endometriosis, said the U.S. Food and Drug Administration identified deficiencies that preclude discussion of labeling and/or post-marketing requirements and commitments at this time.

The companies stated that the FDA did not provide additional detail. The FDA noted that the letter does not reflect a final decision on the pending sNDA and that the application is still under review.

The company said they will continue to work with the FDA to determine next steps with the application.

MYFEMBREE (relugolix, estradiol, and norethindrone acetate) is the once-daily oral treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women approved by the U.S. Food and Drug Administration, with a treatment duration of up to 24 months.

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