FDA Greenlights Generics for NASCOBAL Nasal Vitamin B12 Spray
Published Date: 4/9/2025
Notice
Summary
The FDA says NASCOBAL nasal spray wasn’t taken off the market because of safety or effectiveness problems. This means the spray stays approved, and generic versions can keep getting the green light if they follow the rules. Patients and pharmacies can keep counting on this nasal spray without any interruptions or extra costs.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
FDA Keeps NASCOBAL Approval
The FDA determined that NASCOBAL (cyanocobalamin) nasal spray, 0.5 mg/spray, was not withdrawn from sale for reasons of safety or effectiveness. Because of that finding, the FDA will not start procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this product and will continue to approve ANDAs that refer to it so long as they meet legal and regulatory requirements.
Patients’ Access and Costs Unchanged
You can keep relying on NASCOBAL (cyanocobalamin) nasal spray, 0.5 mg/spray, because the FDA found it was not withdrawn for safety or effectiveness. The FDA says approvals for ANDAs that refer to this product will continue, and the spray’s availability should continue without interruptions or extra costs.
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