Lybrel FDA Approval History

FDA Approved: Yes (Discontinued) (First approved May 22, 2007)
Brand name: Lybrel
Generic name: levonorgestrel and ethinyl estradiol
Dosage form: Tablets
Company: Wyeth Pharmaceuticals Inc.
Treatment for: Birth Control

Marketing Status: Discontinued

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 timeline for Lybrel

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

Further information

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Medical Disclaimer

Drug Status

Availability Discontinued

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

Lybrel FDA Approval History

Development timeline for Lybrel

See also

Further information