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Lybrel Approval History

  • FDA approved: Yes (First approved May 22nd, 2007)
  • Brand name: Lybrel
  • Generic name: levonorgestrel and ethinyl estradiol
  • Dosage form: Low Dose Continuous Regimen
  • Company: Wyeth Pharmaceuticals Inc.
  • Treatment for: Birth Control

Lybrel (levonorgestrel and ethinyl estradiol) is a low-dose combination contraceptive pill taken continuously (without a pill-free interval) and over time may eliminate scheduled menstrual periods. Lybrel is indicated for the prevention of pregnancy.

Development History and FDA Approval Process for Lybrel

DateArticle
May 23, 2007Approval FDA Approves Lybrel, First Low Dose Combination Oral ContraceptiveOffering Women the Opportunity to Be Period-Free Over Time
Jun 28, 2006Wyeth Receives Approvable Letter From the FDA for Lybrel
Jul 27, 2005Wyeth's New Drug Application for New Oral Contraceptive With Uninterrupted Dosing Regimen Accepted for Filing at FDA

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