Relieves non-infectious diarrhea. NDA 202292, held by Napo Pharms Inc. Crofelemer.
As of Nov 14, 2026, NDA 202292 (Mytesi), held by Napo Pharms Inc, was first approved by FDA on Dec 31, 2012, with 5 approved supplements and 0 published complete response letters.
MYTESI is indicated for symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy. MYTESI is an anti-diarrheal indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 31, 2012 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mytesi125MG · tablet, delayed release;oral | Crofelemer | RxReference drug |
| Apr 3, 2024 | Supplement 9Labeling · Standard review | Approved | |
| Nov 16, 2020 | Supplement 7Labeling · Standard review | Approved | |
| Mar 6, 2018 | Supplement 6Labeling · Standard review | Approved | |
| Aug 20, 2014 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Nov 6, 2013 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Dec 31, 2012 | Original applicationNew molecular entity · Priority 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
