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Phexxi FDA Approval History

FDA Approved: Yes (First approved May 22, 2020)
Brand name: Phexxi
Generic name: lactic acid, citric acid and potassium bitartrate
Dosage form: Vaginal Gel
Previous Name: Amphora
Company: Evofem, Inc.
Treatment for: Birth Control

Phexxi (lactic acid, citric acid and potassium bitartrate) is a non-hormonal vaginal gel indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.

  • How well does Phexxi work?
    Your chance of getting pregnant depends on how well you follow the directions for using Phexxi. The better you follow the directions, the less chance you have of getting pregnant. It is very important that you follow the directions carefully each time you have vaginal sex. Phexxi is not effective for the prevention of pregnancy when administered after intercourse.
  • Phexxi is administered by inserting one pre-filled single-dose applicator into the vagina immediately before (or up to one hour before) each episode of vaginal intercourse.
  • Common adverse reactions (≥2%) include vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal mycotic infection, urinary tract infection, vulvovaginal discomfort, bacterial vaginosis, vaginal discharge, genital discomfort, dysuria, and vulvovaginal pain.

Development Timeline for Phexxi

DateArticle
May 22, 2020Approval  FDA Approves Phexxi (lactic acid, citric acid and potassium bitartrate) Non-Hormonal Prescription Gel for the Prevention of Pregnancy
Dec 18, 2019U.S. FDA Acknowledges Receipt of Evofem Biosciences' New Drug Application Resubmission for Amphora for the Prevention of Pregnancy
Nov 26, 2019Evofem Biosciences Resubmits New Drug Application to U.S. FDA for Amphora® for the Prevention of Pregnancy
Feb 21, 2018Evofem Biosciences Receives Fast Track Designation for Amphora for Prevention of Chlamydia
Sep 22, 2015Evofem, Inc. Announces FDA Acceptance of New Drug Application for Amphora as a Contraceptive
Jul  6, 2015Evofem, Inc. Submits NDA to U.S. FDA for Amphora as a Contraceptive

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.