Reference Drug (NDA number): Aldara® (imiquimod) 5% Cream (NDA 20-723), Graceway Pharmaceuticals. Date of approval: 2/27/97
Approved indication(s) based on label approved on 3/22/07: For the topical treatment of:
- clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AK) on the face or scalp in immunocompetent adults,
- biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults; maximum tumor diameter of 2.0 cm on trunk, neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured.
Why isn't Imiquimod Cream 5% recommended for the treatment of superficial basal cell carcinoma located on the face?