The US FDA Extends Review Period of Myfembree’s sNDA to Treat Moderate to Severe Pain Associated with Endometriosis
Shots:
- Myovant & Pfizer reported that the US FDA has extended the review period of sNDA for Myfembree to manage mod. to sev. pain associated with endometriosis
- The FDA requires extended time to review additional information submitted by the companies regarding bone mineral density. The PDUFA date has been extended to Aug 2022
- Myfembree (relugolix 40mg, estradiol 1mg, and norethindrone acetate 0.5mg) has received the US FDA’s approval in the US for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women with a treatment duration of ~24mos.
Ref: Pfizer | Image: Pfizer
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