Treats cutaneous manifestations of cutaneous T-cell lymphoma. NDA 21055, held by Bausch. Bexarotene.
As of Nov 15, 2026, NDA 21055 (Targretin), held by Bausch, was first approved by FDA on Dec 29, 1999, with 9 approved supplements and 0 published complete response letters.
TARGRETIN (bexarotene) Capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.
| Jul 29, 2015 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Dec 29, 1999 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Targretin75MG · capsule;oral | Bexarotene | RxReference drug |
| Sep 14, 2015 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Jul 29, 2015 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Dec 2, 2014 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Jan 6, 2012 | Supplement 8Labeling · Standard review | Approved | |
| May 16, 2011 | Supplement 6Labeling · Standard review | Approved | |
| Apr 21, 2003 | Supplement 2Labeling · Standard review | Approved | |
| Apr 21, 2003 | Supplement 3Labeling · Standard review | Approved | |
| Jan 29, 2002 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Feb 14, 2001 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Dec 29, 1999 | 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
