Prevents pregnancy in females of reproductive potential. NDA 208352, held by Evofem Inc. Citric Acid; Lactic Acid; Potassium Bitartrate.
As of Nov 13, 2026, NDA 208352 (Phexx), held by Evofem Inc, was first approved by FDA on May 22, 2020, with 2 approved supplements and 1 published complete response letter.
PHEXX is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 22, 2020 | Original applicationTYPE 3/4 · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Apr 28, 2016 | NDA 208352Clinical, Facility Inspections, Center For Devices And Radiological Health | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Phexx1%;1.8%;0.4% · gel;vaginal | Citric Acid; Lactic Acid; Potassium Bitartrate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 21, 2025 | Supplement 5Labeling · Standard review | Approved | |
| Feb 8, 2022 | Supplement 2Labeling · Standard review | Approved | |
| May 22, 2020 | Original applicationTYPE 3/4 · 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
