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The US FDA Extends Review Period of Myfembree’s sNDA to Treat Moderate to Severe Pain Associated with Endometriosis

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The US FDA Extends Review Period of Myfembree’s sNDA to Treat Moderate to Severe Pain Associated with Endometriosis

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 

Click here to­ read the full press release 

Neha

Neha Madan is a content writer at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots.

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