Prevents pregnancy. ANDA 91247, held by Novast Labs. Desogestrel; Ethinyl Estradiol.
As of Nov 15, 2026, ANDA 91247 (Pimtrea), held by Novast Labs, was first approved by FDA on Aug 1, 2013, with 5 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE PIMTREA TM (Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. Adapted from Hatcher et al., 1998, Ref#1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 1, 2013 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pimtrea0.15MG,N/A;0.02MG,0.01MG · tablet;oral-28 | Desogestrel; Ethinyl Estradiol | Rx |
| Jul 8, 2024 | Supplement 10Labeling · Standard review | Approved | None posted |
| Apr 29, 2022 | Supplement 9Labeling · Standard review | Approved | None posted |
| Dec 31, 2020 | Supplement 8Labeling · Standard review | Approved | None posted |
| Oct 28, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 9, 2017 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 1, 2013 | Original application | Approved | None posted |
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
