Mirena

Prevents pregnancy for up to 8 years. NDA 21225, held by Bayer Hlthcare. Levonorgestrel.

As of Nov 14, 2026, NDA 21225 (Mirena), held by Bayer Hlthcare, was first approved by FDA on Dec 6, 2000, with 26 approved supplements and 0 published complete response letters.

First approved: Dec 6, 2000
Review: Standard
Supplements approved: 26
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Mirena is a progestin-containing intrauterine system (IUS) indicated for:

Prevention of pregnancy for up to 8 years
Treatment of heavy menstrual bleeding for women who choose to use intrauterine contraception as their method of contraception for up to 5 years. 1.1 Contraception Mirena is indicated for prevention of pregnancy for up to 8 years; replace after the end of the eighth year. 1.2 Heavy Menstrual Bleeding Mirena is indicated for the treatment of heavy menstrual bleeding for up to 5 years in women who choose to use intrauterine contraception as their method of contraception; replace after the end of the fifth year if continued treatment of heavy menstrual bleeding is needed.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below


Aug 12, 2022	Supplement 43Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 11, 2021	Supplement 42Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 20, 2020	Supplement 40Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 8, 2017	Supplement 38Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 1, 2009	Supplement 27Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 6, 2000	Original applicationNew dosage form · Standard review	Approved	Review Pediatric Medical Review Pediatric Clinical Pharmacology Review Pediatric Statistical Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mirena52MG · system;intrauterine	Levonorgestrel	RxReference drug

All 27 submissions, including labeling and manufacturing supplements


Aug 12, 2022	Supplement 43Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 11, 2021	Supplement 42Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 8, 2021	Supplement 36Labeling · Standard review	Approved	Label Letter
May 26, 2021	Supplement 41Labeling · Standard review	Approved	Letter
Aug 20, 2020	Supplement 40Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 8, 2017	Supplement 38Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 25, 2017	Supplement 39Labeling · Standard review	Approved	Label Letter
Dec 21, 2016	Supplement 37Labeling · Standard review	Approved	Letter Label
Oct 22, 2015	Supplement 31Labeling · Standard review	Approved	Review Letter Label
Dec 8, 2014	Supplement 35Manufacturing · Standard review	Approved	None posted
May 29, 2014	Supplement 33Manufacturing · Standard review	Approved	Review Label
May 8, 2014	Supplement 34Manufacturing · Standard review	Approved	None posted
Mar 7, 2014	Supplement 29Manufacturing · Standard review	Approved	None posted
Aug 7, 2013	Supplement 32Labeling · Standard review	Approved	Label Letter
Oct 1, 2009	Supplement 27Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jul 21, 2008	Supplement 19Labeling · Standard review	Approved	Letter Label
Jun 2, 2008	Supplement 18Labeling · Standard review	Approved	Letter
May 28, 2008	Supplement 17Labeling · Standard review	Approved	Letter
Jan 8, 2004	Supplement 9Labeling · Standard review	Approved	Letter
Aug 27, 2003	Supplement 10Manufacturing · Standard review	Approved	Letter
Nov 27, 2002	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 29, 2002	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 4, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
Dec 5, 2001	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 29, 2001	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 12, 2001	Supplement 2Labeling · Standard review	Approved	None posted
Dec 6, 2000	Original applicationNew dosage form · Standard review	Approved	Review Pediatric Medical Review Pediatric Clinical Pharmacology Review Pediatric Statistical Review

Identifiers

Application: NDA 21225
Drugs@FDA: Overview at FDA
Company: Bayer Healthcare

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters