Expanded indications for intranasal Nascobal in Vitamin B-12 supplementation
UNION CITY, CALIF., September 9, 2003 -- Questcor Pharmaceuticals announced that it has received a letter from the FDA approving the company's request to have Nascobal labeled for first-line use for all Vitamin B-12 deficiencies except pernicious anemia. Previously, the approved Nascobal labeling required the initial stabilization of Vitamin B-12 levels with injectable Vitamin B-12 before switching to intranasal Nascobal.
Non-pernicious anemia patients, such as Crohn's disease or MS sufferers, with Vitamin B-12 deficiencies can now be started, as well as maintained, intranasally with Nascobal. Previously, Vitamin B-12 injections were necessary for initiation of Vitamin B-12 supplementation in these patients. Nascobal is the only non-injectable treatment option for Vitamin B-12 deficiencies currently available by prescription. The product is dosed as one squirt, in one nostril, once a week, thereby avoiding painful monthly intramuscular injections.
Posted: September 2003