Treats cutaneous lesions. NDA 20886, held by Advanz Pharma. Alitretinoin.
As of Nov 13, 2026, NDA 20886 (Panretin), held by Advanz Pharma, was first approved by FDA on Feb 2, 1999, with 4 approved supplements and 0 published complete response letters.
1.1 Kaposi’s Sarcoma PANRETIN GEL is indicated for topical treatment of cutaneous lesions in adults with AIDS related Kaposi’s sarcoma (KS). Limitations of Use: PANRETIN GEL is not indicated when systemic anti-KS therapy is required (including more than 10 new KS lesions in the prior month, symptomatic lymphedema, symptomatic pulmonary KS, or symptomatic visceral involvement). PANRETIN GEL is a retinoid indicated for the topical treatment of cutaneous lesions in adults with AIDS-related Kaposi’s sarcoma (KS). Limitations of Use: PANRETIN GEL is not indicated when systemic anti-Kaposi’s sarcoma therapy is required.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 2, 1999 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| PanretinEQ 0.1% BASE · gel;topical | Alitretinoin | RxReference drug |
| Nov 17, 2025 | Supplement 9Labeling · Standard review | Approved | |
| Nov 22, 2013 | Supplement 6Manufacturing | Approved | None posted |
| Nov 21, 2000 | Supplement 2Manufacturing | Approved | None posted |
| Jul 12, 1999 | Supplement 1Manufacturing | Approved | None posted |
| Feb 2, 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
