Nastech Pharmaceutical Company Inc has announced receipt of an approvable letter from the US 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.
Gordon C. Brandt, executive vice president, Clinical Research and Medical Affairs of Nastech said, "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."
Nascobal Nasal Gel has been approved and marketed in the US since 1997 for the treatment of various vitamin B-12 deficiencies and has a proven track record of safety and efficacy. Nascobal Nasal Gel is indicated for use in patients with pernicious anaemia, Crohn's Disease, HIV/AIDS, and Multiple Sclerosis as well as other mal-absorptive conditions that can result in vitamin B-12 deficiency.