Why isn't Imiquimod Cream 5% recommended for the treatment of superficial basal cell carcinoma located on the face?
I read on Approval Package for Imiquimod Cream, 5% on February 25, 2010 (mirror):
Reference Drug (NDA number): Aldaraź (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?
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