Scolr’s ANDA for CDT-Based Pseudoephedrine Accepted for Review By FDA
Scolr Pharma, a specialty pharmaceutical company, has announced that the FDA has accepted for review the company’s abbreviated new drug application for a 120mg 12-hour pseudoephedrine tablet based on its patented controlled delivery technology platform.
The abbreviated new drug application (ANDA) was submitted to the FDA on August 5, 2008. This is said to be the first application filed by Scolr Pharma with the FDA.
Pseudoephedrine is a decongestant that is an active ingredient in Allegra D, Sudafed PSE, Claritin D, Zyrtec D and other over-the-counter and prescription products.
Tanya Raco, associate vice president of regulatory affairs and quality assurance at Scolr Pharma, said: “We believe the timely notification received from the FDA is a testimony to the quality of our filing. If approved by the FDA, our pseudoephedrine formulation could provide important competitive advantages over existing marketed formulations in terms of both tablet size and manufacturing costs.”