Treats relapsed or refractory peripheral T-cell lymphoma (PTCL). NDA 22468, held by Acrotech Biopharma. Pralatrexate.
As of Nov 14, 2026, NDA 22468 (Folotyn), held by Acrotech Biopharma, was first approved by FDA on Sep 24, 2009, with 10 approved supplements and 0 published complete response letters.
FOLOTYN is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 24, 2009 | Original applicationNew molecular entity · Priority review | Approved |
| Folotyn20MG/ML (20MG/ML) · solution;intravenous | Pralatrexate | RxReference drug |
| Folotyn40MG/2ML (20MG/ML) · solution;intravenous | Pralatrexate | RxReference drug |
| Oct 20, 2020 | Supplement 14Labeling · Standard review | Approved | |
| May 14, 2020 | Supplement 13Labeling · Standard review | Approved | |
| May 13, 2016 | Supplement 12Labeling · Standard review | Approved | |
| May 30, 2012 | Supplement 11Labeling · Standard review | Approved | |
| May 30, 2012 | Supplement 10Labeling · Standard review | Approved | |
| Feb 15, 2012 | Supplement 9Labeling | Approved | |
| Jan 7, 2011 | Supplement 5Labeling | Approved | |
| Jan 7, 2011 | Supplement 4Labeling | Approved | |
| Jan 7, 2011 | Supplement 3Labeling | Approved | |
| Apr 26, 2010 | Supplement 1Labeling | Approved | |
| Sep 24, 2009 | 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
