SCOLR Pharma, Inc. (OTC Bulletin Board: SCLR) today announced it has received a letter from the Food and Drug Administration (FDA) identifying deficiencies regarding its Abbreviated New Drug Application (ANDA) for extended-release pseudoephedrine.
The Company said the letter identified a number of concerns that the FDA had with the conduct of the bioequivalence study submitted by SCOLR to support the application. The deficiencies cited relate to the design and conduct of the study. None of the issues raised relate to the product formulation. Due to these deficiencies, the agency said it is unable to approve the ANDA application at this time.
Stephen J. Turner, SCOLR Pharma's President and CEO, said: "Although we are extremely disappointed with this situation, we are currently evaluating the deficiencies identified by the FDA to determine the most appropriate course of action. We remain confident in our pseudoephedrine product and intend to rectify the FDA's concerns."