Drug Development

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

Published in Medical Letter on the CDC and FDA, February 8th, 2009

SCOLR Pharma, Inc. (AMEX:DDD) announced that the U. S. Food and Drug Administration (FDA) has issued a Complete Response letter for its Abbreviated New Drug Application (ANDA) 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 Complete Response letter requests additional information, all of which was identified by the FDA as "minor." The Company said that it believes it can provide the information to the FDA expeditiously. None of the issues cited by the FDA involve the safety or efficacy of the product.

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Source: Medical Letter on the CDC and FDA (2009-02-08)

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