Twirla Approval History
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 History and FDA Approval Process for Twirla
|Feb 14, 2020|| 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|
|May 6, 2017||Agile Therapeutics Reports Additional Phase 3 SECURE Study Results Relating to Twirla|
|Oct 26, 2010||Agile Therapeutics Announces Study Results Demonstrating Contraceptive Patch AG200-15 Delivers a Low Dose of Estrogen|
|Dec 9, 2008||Agile Therapeutics Abstracts on Lead Product, AG200-15 Accepted by ACOG|
|Sep 3, 2008||Agile Therapeutics Achieves Phase 2 Study Endpoints in Key Clinical Trials with New, Innovative Low-Dose Contraceptive Patch|
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