Search Results for keywords:"Discontinued Drug Product List"

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.

The Food and Drug Administration (FDA) has determined that the drug VIBRAMYCIN (doxycycline) for oral suspension was not taken off the market due to safety or effectiveness concerns. This decision allows the FDA to continue approving generic versions of this medication as long as they meet legal and regulatory criteria. VIBRAMYCIN is included in the “Discontinued Drug Product List” because it was removed from sale for reasons unrelated to safety or effectiveness. If necessary, the FDA may require updates to the drug’s labeling to align with current standards.

The Food and Drug Administration (FDA) has determined that DECADRON, a medication with the active ingredient dexamethasone sodium phosphate, was not taken off the market for reasons related to safety or effectiveness. This decision allows continued approval of generic versions of the drug as long as they comply with necessary legal and regulatory standards. DECADRON will remain on the "Discontinued Drug Product List," which includes drugs discontinued for reasons other than safety or effectiveness. The FDA reviewed data and found no evidence of safety concerns leading to the drug's withdrawal.