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Aldara deemed approvable by U.S. FDA.
2004 MAY 14 - (NewsRx.com & NewsRx.net) -- 3M has received an approvable letter from the U.S. Food and Drug Administration (FDA) in response to its supplemental new drug application on Aldara (imiquimod) Cream, 5% for the treatment of superficial basal cell carcinoma (sBCC), a common form of non-melanoma skin cancer.
The FDA noted no major deficiencies in the application and requested 3M provide additional safety data as a condition of approval. 3M plans to submit such additional data from completed clinical studies shortly. Given that FDA ...
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