FDA Scolds SCOLR for Deficient ANDA Filing

SCOLR Pharmaceuticals said it has been scolded by the FDA for an inadequate Abbreviated New Drug Application for extended-release pseudoephedrine.

According to SCOLR, the regulatory letter outlined 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." The FDA then rejected the ANDA.

"Although we