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news.The Food and Drug Administration (FDA) has issued deficiency letter to SCOLR Pharma related to its abbreviated new drug application (ANDA) for extended-release Pseudoephedrine.
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FDA’s decision is supported by the identification of deficiencies in the conduct and design of the bioequivalence study which was submitted by the company in support of Pseudoephedrine ANDA.
SCOLR Pharma said that the FDA has not questioned on the formulation of the product.
SCOLR Pharma president and CEO Stephen Turner said although they are extremely disappointed with this situation, they 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," Turner said.