Bothell, WA-based SCOLR Pharmaceuticals 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 are extremely disappointed with this situation, we are currently evaluating the deficiencies identified by the FDA to determine the most appropriate course of action," says SCOLR CEO Stephen J. Turner, who was named to the helm in 2009. "We remain confident in our pseudoephedrine product and intend to rectify the FDA's concerns."
- here's the SCOLR release