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Liletta FDA Approval History

Last updated by Judith Stewart, BPharm on July 11, 2023.

FDA Approved: Yes (First approved February 26, 2015)
Brand name: Liletta
Generic name: levonorgestrel
Dosage form: Intrauterine Device
Company: Medicines360
Treatment for: Birth Control, Heavy Menstrual Bleeding

Liletta (levonorgestrel) is a progestin-containing intrauterine system indicated for the prevention of pregnancy for up to 8 years, and the treatment of heavy menstrual bleeding for up to 5 years in patients who choose intrauterine contraception as their method of contraception.

Development timeline for Liletta

DateArticle
Jul 10, 2023Approval FDA Approves Medicines360’s Supplemental New Drug Application for Liletta (levonorgestrel-releasing intrauterine system) 52 mg as Treatment of Heavy Menstrual Bleeding
Nov 14, 2022Approval FDA Approves Medicines360’s Liletta (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Eight Years
Oct 28, 2019Approval FDA Approves Liletta (levonorgestrel-releasing intrauterine system) to Prevent Pregnancy for up to Six Years
Oct 16, 2018Approval FDA Approves Liletta (levonorgestrel-releasing intrauterine system) to Prevent Pregnancy for up to Five Years
Aug  6, 2017Approval FDA Approves Liletta (levonorgestrel-releasing intrauterine system) to Prevent Pregnancy for up to Four Years
Feb 27, 2015Approval FDA Approves Liletta (levonorgestrel-releasing intrauterine system) to Prevent Pregnancy for up to Three Years
Jul 21, 2014Medicines360 and Actavis Announce FDA Acceptance for Filing of NDA for Levosert IUD

See also

Liletta (levonorgestrel) Consumer information

Further information

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