The Food and Drug Administration (FDA) has determined that NASCOBAL, a nasal spray containing 0.5 mg of cyanocobalamin (vitamin B12), was not removed from the market due to safety or effectiveness concerns. This decision means that the FDA will continue to approve generic versions of NASCOBAL as long as they meet all legal and regulatory requirements. The drug remains listed in the "Discontinued Drug Product List" section of the Orange Book, which indicates it was not discontinued for safety reasons. If needed, the FDA will instruct generic drug makers to update their labeling to current standards.
Simple Explanation
The FDA checked on a special vitamin B12 nose spray called NASCOBAL and said it wasn’t stopped because it was unsafe or didn't work. This means other companies can still make the same kind of spray if they follow all the rules.