Review of injectable tretinoin by FDA's Oncologic Drugs Advisory Committee scheduled for Sept. 17 is cancelled by the agency due to "deficiencies" found by FDA in Atragen's NDA, the company announces Aug. 5
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FDA notified the firm that its injectable tretinoin product for acute promyelocytic leukemia is "not approvable." A scheduled review of the drug by FDA's Oncologic Advisory Committee was previously cancelled (1"The Pink Sheet" Aug. 9, In Brief)
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011