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news.SCOLR Pharma has received FDA clearance to begin US testing of its 12-hour extended release ibuprofen tablets, in a study that will support a new drug application planned for submission later this year.
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SCOLR Pharma also confirmed its intention to initiate bioequivalency testing of its extended release pseudoephedrine decongestant tablets to support an anticipated abbreviated new drug application (ANDA) expected to be submitted this summer.
Tanya Raco, SCOLR Pharma’s director of quality and regulatory affairs, stated, “We are pleased to have received timely feedback from the FDA on our IND (investigational new drug application) for our 12-hour extended release ibuprofen tablets. We expect to initiate clinical testing in late March or early April.” Raco also confirmed that the company has scheduled its 12-hour pseudoephedrine evaluation to begin in late February.
Both products are designed for the US over-the-counter (OTC) market and are based on the company’s controlled delivery technology (CDT) platform.
The company’s CEO, Daniel Wilds, said that the SCOLR Pharma is in discussions with potential corporate partners or licensees for both products.