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Nextstellis FDA Approval History

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.

  • Nextstellis is the first oral contraceptive to contain estetrol (E4), a synthetic analogue of a native estrogen present during pregnancy.
  • Nextstellis tablets are taken once daily, with 24 active tablets and 4 inert tablets in each 28 day cycle.
  • Nextstellis comes with a boxed warning for cigarette smoking and serious cardiovascular events. Common adverse reactions include bleeding irregularities, mood disturbance, headache, breast symptoms, dysmenorrhea, acne, increased weight, and decreased libido.

Development Timeline for Nextstellis

DateArticle
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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