alitretinoin

FDA Drug Profile — PANRETIN

Drug Details

Generic Name
alitretinoin
Brand Names
PANRETIN
Application Number
NDA020886
Sponsor
Advanz Pharma (US) Corp.
NDC Codes
1
Dosage Forms
GEL
Routes
TOPICAL
Active Ingredients
ALITRETINOIN

Indications and Usage

1 INDICATIONS AND USAGE 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) [see Clinical Studies ( 14.1 )] . 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.