Treats homocystinuria. NDA 20576, held by Recordati Rare. Betaine.
As of Nov 13, 2026, NDA 20576 (Cystadane), held by Recordati Rare, was first approved by FDA on Oct 25, 1996, with 8 approved supplements and 0 published complete response letters.
CYSTADANE is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations in pediatric and adult patients. Included within the category of homocystinuria are: Cystathionine beta-synthase (CBS) deficiency 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency Cobalamin cofactor metabolism (cbl) defect CYSTADANE is a methylating agent indicated in pediatric and adult patients for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 25, 1996 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cystadane1GM/SCOOPFUL · for solution;oral | Betaine | RxReference drug |
| Nov 6, 2018 | Supplement 14Labeling · Standard review | Approved | |
| Apr 5, 2010 | Supplement 10Labeling · Standard review | Approved | |
| Feb 17, 2006 | Supplement 8Labeling · Standard review | Approved | |
| Aug 25, 2000 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Jan 21, 2000 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Mar 16, 1999 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 13, 1998 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| May 5, 1998 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 25, 1996 | 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
