tazarotene

FDA Drug Profile — TAZAROTENE, FABIOR, Tazorac, TAZORAC, Arazlo

Drug Details

Generic Name
tazarotene
Brand Names
TAZAROTENE, FABIOR, Tazorac, TAZORAC, Arazlo, tazarotene
Application Number
ANDA217075
Sponsor
Padagis Israel Pharmaceuticals Ltd
NDC Codes
14
Dosage Forms
CREAM, GEL, AEROSOL, FOAM, LOTION
Routes
TOPICAL, CUTANEOUS
Active Ingredients
TAZAROTENE

Indications and Usage

1 INDICATIONS AND USAGE • Tazarotene gel, 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. ( 1.1 ) • Tazarotene gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. ( 1.2 ) Limitations of Use • The safety of tazarotene gel use on more than 20% body surface area has not been established. ( 1.3 ) 1.1 Plaque Psoriasis Tazarotene gel, 0.05% and 0.1% are indicated for the topical treatment of patients with plaque psoriasis of up to 20% body surface area involvement. 1.2 Acne Vulgaris Tazarotene gel, 0.1% is also indicated for the topical treatment of patients with facial acne vulgaris of mild to moderate severity. The efficacy of tazarotene gel in the treatment of acne previously treated with other retinoids or resistant to oral antibiotics has not been established. 1.3 Limitations of Use The safety of tazarotene gel use on more than 20% body surface area has not been established in psoriasis or acne [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)] .