Twirla FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 27, 2021.
FDA Approved: Yes (First approved February 14, 2020)
Brand name: Twirla
Generic name: ethinyl estradiol and levonorgestrel
Dosage form: Transdermal System
Company: Agile Therapeutics, Inc.
Treatment for: Birth Control
Twirla (ethinyl estradiol and levonorgestrel transdermal system) is a low-dose combined hormonal contraceptive patch for birth control.
Development timeline for Twirla
| Date | Article |
|---|
| Feb 14, 2020 | Approval FDA Approves Twirla (levonorgestrel and ethinyl estradiol) Contraceptive Patch |
| Nov 14, 2019 | Agile Therapeutics Announces FDA Extension of Twirla NDA Review Period |
| Oct 30, 2019 | Agile Therapeutics Announces Favorable Outcome of FDA Advisory Committee Meeting for its Investigational Transdermal Contraceptive Patch, Twirla (AG200-15) |
| May 17, 2019 | Agile Therapeutics Resubmits New Drug Application (NDA) for its Transdermal Low-Dose Contraceptive Patch, Twirla |
| May 18, 2018 | Agile Therapeutics, Inc. Provides Regulatory Update on Twirla (AG200-15) for the Prevention of Pregnancy |
| Dec 22, 2017 | Agile Therapeutics, Inc. Receives a Complete Response Letter from the FDA for Twirla (AG200-15) for the Prevention of Pregnancy |
| Jul 27, 2017 | Agile Therapeutics Announces FDA Acceptance of the NDA Resubmission of Twirla |
| Jun 27, 2017 | Agile Therapeutics Resubmits New Drug Application for its Transdermal Contraceptive Patch, Twirla |
Further information
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