Scolr Pharma intends to file a new drug application (NDA) known as a 505(b)(2) application, which can be used for products for which substantial evidence of safety and efficacy already exist.
Scolr Pharma also announced completion of dosing in the last two study segments of its bioequivalence testing in support of an abbreviated new drug application (ANDA) for its 12-hour extended release CDT-pseudoephedrine tablets. The ANDA is planned for submission to the FDA this summer and will require that the product be shown to meet applicable bioequivalence standards.
Daniel Wilds, Scolr Pharma’s president and CEO, commented, “These clinical developments represent attainment of significant milestones for our company. Ibuprofen and pseudoephedrine formulated with our controlled delivery technology (CDT) represent the first two novel formulations in our growing portfolio of drug candidates with significant market potential.
“We expect to continue discussions with interested potential licensing and/or distribution partners as the clinical evaluation and US regulatory approval process for these products progress and we proceed with the development of other product candidates.”