SCOLR decongestant delays to be "minor"

Bellevue, Washington, USA-based SCOLR Pharma has received a "complete response" letter from the Food and Drug Administration for its  abbreviated New Drug Application for the decongestant 120mg, 12-hour  pseudoephedrine tablets based on its Controlled Delivery Technology  platform.

The letter requests additional information, all of which was identified  by the FDA as "minor." The company said that it believes it can provide  a response expeditiously and adds that none of the issues cited by the  agency involve the safety or efficacy of the product.

Associate vice president, Tanya Raco said: "we are pleased that the FDA  has moved so quickly to review our application. If approved, this would  be SCOLR's first successful product applicationbut, more importantly, it  would provide additional validation for our underlying  technology."