Scolr Pharma Files ANDA for Pseudoephedrine Formulation
Scolr Pharma has submitted an abbreviated new drug application for a 120mg 12-hour pseudoephedrine tablet based on the company’s patented controlled delivery technology platform to the FDA.
This is said to be the first application submitted by Scolr based on its controlled delivery technology platform. Pseudoephedrine is an active ingredient in Allegra D, Sudafed PSE, Claritin D, Zyrtec D and other over-the-counter (OTC) and prescription products as a decongestant.
The company expects to complete the ibuprofen trial late this year. If approved, the company believes its ibuprofen product would be the first and only OTC 12-hour, extended-release ibuprofen product on the market in the US.
Daniel Wilds, CEO of Scolr Pharma, said: “The abbreviated new drug application (ANDA) for pseudoephedrine is a major accomplishment for Scolr. Approval of this product would further substantiate some of the unique advantages of our drug delivery technology and can be an important revenue contributor to our business in the future.”