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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, 2020Approval FDA Approves Twirla (levonorgestrel and ethinyl estradiol) Contraceptive Patch
Nov 14, 2019Agile Therapeutics Announces FDA Extension of Twirla NDA Review Period
Oct 30, 2019Agile Therapeutics Announces Favorable Outcome of FDA Advisory Committee Meeting for its Investigational Transdermal Contraceptive Patch, Twirla (AG200-15)
May 17, 2019Agile Therapeutics Resubmits New Drug Application (NDA) for its Transdermal Low-Dose Contraceptive Patch, Twirla
May 18, 2018Agile Therapeutics, Inc. Provides Regulatory Update on Twirla (AG200-15) for the Prevention of Pregnancy
Dec 22, 2017Agile Therapeutics, Inc. Receives a Complete Response Letter from the FDA for Twirla (AG200-15) for the Prevention of Pregnancy
Jul 27, 2017Agile Therapeutics Announces FDA Acceptance of the NDA Resubmission of Twirla
Jun 27, 2017Agile Therapeutics Resubmits New Drug Application for its Transdermal Contraceptive Patch, Twirla
May  6, 2017Agile Therapeutics Reports Additional Phase 3 SECURE Study Results Relating to Twirla
Oct 26, 2010Agile Therapeutics Announces Study Results Demonstrating Contraceptive Patch AG200-15 Delivers a Low Dose of Estrogen
Dec  9, 2008Agile Therapeutics Abstracts on Lead Product, AG200-15 Accepted by ACOG
Sep  3, 2008Agile Therapeutics Achieves Phase 2 Study Endpoints in Key Clinical Trials with New, Innovative Low-Dose Contraceptive Patch

Further information

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