SCOLR Pharma, Inc.has announced that the 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. Tanya Raco, the company’s Associate Vice President of Regulatory Affairs and Quality Assurance, said, “We are pleased that the FDA has moved so quickly to review our application. If approved, this would be SCOLR’s first successful product application, but more importantly it would provide additional validation for our underlying technology. We will continue to work closely with the FDA to address the questions raised and advance our CDT(R) 12-hour pseudoephedrine toward approval.” SCOLR is currently in discussions with potential partners for an alliance for this product, but is still open to talk with other companies about this opportunity.
