FDA approves Nastech vitamin B-12 deficiency nasal spray

Nov 1 2004

Nastech Pharmaceutical Company has announced receipt of an approvable letter from the U.S. Food and Drug Administration (FDA) on Nascobal (Cyanocobalamin, USP) Nasal Spray for the treatment of vitamin B-12 deficiency.

Nascobal Nasal Spray was developed by Nastech as an alternative to Nascobal Nasal Gel and worldwide marketing rights to both products were divested to Questcor Pharmaceuticals, Inc. in June 2003. Nastech will manufacture the product for Questcor following final approval by the FDA under terms of a supply agreement with Questcor.

Remaining items to be completed for product approval are an FDA inspection of a supplier's B-12 raw material manufacturing facility and finalization of the product labeling. There were no FDA requirements for additional work related to manufacturing, preclinical, or clinical studies.

"We are encouraged by the timely review of the Nascobal Nasal Spray application by the FDA and we believe that we can close these issues resulting in NDA approval in the near future," said Gordon C. Brandt, M.D., Executive Vice President, Clinical Research and Medical Affairs of Nastech. "FDA approval of this application will potentially provide the approximately 116,000 patients who currently receive monthly intramuscular B-12 injections with access to a more convenient, patient friendly treatment for vitamin B-12 deficiency."