I read on Approval Package for Imiquimod Cream, 5% on February 25, 2010 (mirror):

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:

  1. clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AK) on the face or scalp in immunocompetent adults,
  2. 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?

  • A 10-year old FDA approval doesn't mean doctors aren't using it in off-label ways. So who says it's not recommended?
    – Carey Gregory
    Nov 13, 2020 at 23:53
  • @CareyGregory The Center for Drug Evaluation and Research, since the face isn't mentioned in the approval package. Nov 14, 2020 at 0:07
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    And flecainide isn't approved for the treatment of atrial fibrillation either, but it's been a mainstay of treatment for years. You can't go by FDA approvals. Drugs get used off label all the time.
    – Carey Gregory
    Nov 14, 2020 at 0:25
  • As Carey suggests, you have not cited evidence of "not recommended", you've cited evidence of "not approved for marketing by the FDA". Often "why" questions for the latter resolve to "because the manufacturer did not choose to pursue approval for that indication" which in turn boils down to the benefit of adding an indication to a label vs the expensive cost of clinical research.
    – Bryan Krause
    Nov 14, 2020 at 19:59


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