SCOLR announces issue of Complete Response letter by FDA for its Abbreviated New Drug Application

BOTHELL, Wash. SCOLR Pharma last week announced that the Food and Drug Administration recently issued a Complete Response letter regarding its Abbreviated New Drug Application for a controlled-delivery formulation of pseudoephedrine.

"We are pleased that the FDA has moved so quickly to review our application,” stated Tanya Raco, SCOLR associate VP regulatory affairs and quality assurance. “If approved, this would be SCOLR's first successful product application, but more importantly, it would provide additional validation for our underlying technology."

SCOLR currently is in discussions with potential partners for an alliance for this product, but is still open to talk with other companies about this opportunity, the company stated.

The application, filed by SCOLR Aug. 5, seeks approval to market a 120-mg, 12-hour pseudoephedrine tablet based on its patented Controlled Delivery Technology platform. The Complete Response letter requests additional information, all of which was identified by the FDA as "minor," the company stated.