FDA seeks more data on pseudoephedrine from SCOLR Pharma

01/21/2009 | Pharmaceutical Business Review Online

The FDA issued a complete-response letter asking SCOLR Pharma to provide more data on its 120-mg, 12-hour formulation of pseudoephedrine, a nonprescription drug. SCOLR Pharma said it "will continue to work closely" with the agency to get clearance for the product, which is based on the firm's patented Controlled Delivery Technology platform.

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