Tuesday, January 20, 2009

FDA Issues Complete Response Letter to SCOLR Pharma's Abbreviated New Drug Application for CDT 12-Hour Pseudoephedrine

SCOLR Pharma, Inc. today announced that the U. S. FDA has issued a Complete Response letter for its Abbreviated New Drug Application for pseudoephedrine. The application, filed by SCOLR on August 5, 2008, seeks approval to market a 120 mg 12 hour pseudoephedrine tablet based on its patented Controlled Delivery Technology (CDT(R)) platform.

The details can be read here.

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