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Nextstellis FDA Approval History

Last updated by Judith Stewart, BPharm on May 2, 2021.

FDA Approved: Yes (First approved April 15, 2021)
Brand name: Nextstellis
Generic name: drospirenone and estetrol
Dosage form: Tablets
Company: Mayne Pharma US
Treatment for: Birth Control

Nextstellis (drospirenone and estetrol) is a progestin and estrogen combination indicated for use by females of reproductive potential to prevent pregnancy.

Development timeline for Nextstellis

Apr 15, 2021Approval FDA Approves Nextstellis (drospirenone and estetrol) Oral Contraceptive for Birth Control
Apr 16, 2020Mayne Pharma Submits NDA for E4/DRSP to the FDA

Further information

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