FDA approval for Nascobal Nasal Spray for malabsorptive and diet-related B12 deficiencies
BOTHELL, WASH., February 1, 2005 -- Nastech Pharmaceutical Company announced approval by the FDA of Nascobal (cyanocobalamin, USP) Nasal Spray for the treatment of vitamin B12 (cyanocobalamin) deficiency in patients with pernicious anemia, Crohn's Disease, HIV/AIDS, and multiple sclerosis. Nastech developed Nascobal Nasal Spray as an alternative to Nascobal (cyanocobalamin, USP) Gel for Intranasal Administration, an FDA approved product launched in 1997.
"Due to intestinal inflammation, people with Crohn's disease may have difficulty absorbing vitamin B12," stated Rodger L. DeRose, president and chief executive officer of the Crohn's & Colitis Foundation of America (www.ccfa.org). "We hope that this second delivery system will make Nascobal an option for more Crohn's disease patients who suffer from vitamin B12 deficiency."
Left untreated, vitamin B12 deficiency may lead to anemia, intestinal problems, and irreversible nerve damage. As with Nascobal Nasal Gel, the spray formulation is also indicated for use in patients with pernicious anemia, other malabsorptive conditions that can result in vitamin B12 deficiency such as gastric bypass surgery, Crohn's Disease, HIV/AIDS, and Multiple Sclerosis.
Source: Nastech www.nastech.com
Posted: February 2005