Treats Toxoplasmosis. NDA 8578, held by Tilde Sciences. Pyrimethamine.
As of Nov 14, 2026, NDA 8578 (Daraprim), held by Tilde Sciences, was first approved by FDA on Jan 23, 1953, with 9 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Treatment of Toxoplasmosis: DARAPRIM is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 23, 1953 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Daraprim25MG · tablet;oral | Pyrimethamine | RxReference drug |
| Jun 21, 2017 | Supplement 20Labeling · Standard review | Approved | |
| Mar 16, 2017 | Supplement 19Labeling · Standard review | Approved | |
| Nov 18, 2003 | Supplement 16Labeling · Standard review | Approved | |
| Oct 10, 2002 | Supplement 15Labeling · Standard review | Approved | |
| Apr 8, 1998 | Supplement 10Labeling | Approved | None posted |
| Apr 8, 1998 | Supplement 14Labeling · Standard review | Approved | None posted |
| Mar 25, 1997 | Supplement 13Labeling · Standard review | Approved | None posted |
| Oct 17, 1988 | Supplement 9Labeling | Approved | None posted |
| Feb 20, 1987 | Supplement 8Labeling | Approved | None posted |
| Jan 23, 1953 | 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
