Prevents pregnancy for up to 3 years. NDA 203159, held by Bayer Hlthcare. Levonorgestrel.
As of Nov 13, 2026, NDA 203159 (Skyla), held by Bayer Hlthcare, was first approved by FDA on Jan 9, 2013, with 11 approved supplements and 0 published complete response letters.
Skyla is indicated to prevent pregnancy for up to 3 years. Replace the system after 3 years if continued use is desired. Skyla is a progestin-containing intrauterine system (IUS) indicated for prevention of pregnancy for up to 3 years.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 9, 2013 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Skyla13.5MG · system;intrauterine | Levonorgestrel | RxReference drug |
| May 4, 2023 | Supplement 14Labeling · Standard review | Approved | |
| Jan 12, 2022 | Supplement 13Labeling · Standard review | Approved | |
| May 17, 2021 | Supplement 12Labeling · Standard review | Approved | |
| Mar 1, 2018 | Supplement 10Labeling · Standard review | Approved | |
| Mar 3, 2017 | Supplement 7Labeling · Standard review | Approved | |
| Dec 21, 2016 | Supplement 8Labeling · Standard review | Approved | |
| Nov 2, 2016 | Supplement 6Labeling · Standard review | Approved | |
| Apr 8, 2016 | Supplement 5Labeling · Standard review | Approved | |
| May 8, 2014 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Sep 13, 2013 | Supplement 2Labeling · Standard review | Approved | |
| Aug 7, 2013 | Supplement 1Labeling · Standard review | Approved | |
| Jan 9, 2013 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
