On Wednesday January 26, 2011, GlaxoSmithKline (GSK) announced that the Company has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for the supplemental New Drug Application (sNDA) for Avodart® (Dutasteride CAS# 164656-23-9 available for R&D purposes from LGM Pharma, a US based API supplier) for reducing the risk of prostate cancer in men at increased risk for the disease, defined as those who have had a prior negative biopsy due to clinical concern and have an elevated serum prostate-specific antigen (PSA).
A Complete Response letter is issued by the FDA’s Center for Drug Evaluation and Research when the review of a file is completed and it cannot be approved in its present form. This means the agency would not issue the additional approval for the drug until certain concerns are addressed.
The rejection does not affect Avodart’s existing approval for treating symptoms associated with an enlarged prostate in men.
This notification refers solely to the supplemental file specific to a prostate cancer risk reduction indication and not the existing FDA-approved uses. Avodart is approved for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention (AUR), and reduce the risk of the need for BPH-related surgery In combination with the alpha-blocker tamsulosin, Avodart is also approved for the treatment of symptomatic BPH in men with an enlarged prostate.
There is not telling how long any final FDA decision might take.
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