Treats symptoms of premenstrual dysphoric disorder (PMDD). ANDA 79221, held by Xiromed. Drospirenone; Ethinyl Estradiol.
As of Nov 15, 2026, ANDA 79221 (Loryna), held by Xiromed, was first approved by FDA on Mar 28, 2011, with 6 approved supplements and 0 published complete response letters.
Loryna (drospirenone and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to: Prevent pregnancy. Treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception. Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. 1.1 Oral Contraceptive Loryna (drospirenone and ethinyl estradiol tablets) are indicated for use by women to prevent pregnancy. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 28, 2011 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loryna3MG;0.02MG · tablet;oral | Drospirenone; Ethinyl Estradiol | Rx |
| Aug 16, 2023 | Supplement 18Labeling · Standard review | Approved | None posted |
| Apr 20, 2023 | Supplement 16Labeling · Standard review | Approved | None posted |
| Apr 28, 2020 | Supplement 11Labeling · Standard review | Approved | None posted |
| Apr 28, 2020 | Supplement 13Labeling · Standard review | Approved | None posted |
| Apr 28, 2020 | Supplement 14Labeling · Standard review | Approved | None posted |
| Sep 19, 2012 | Supplement 4Labeling · Standard review | Approved | None posted |
| Mar 28, 2011 | 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
