💊FDA Confirms NASCOBAL Status, Impacting Generic Approvals
Determination That NASCOBAL (Cyanocobalamin) Nasal Spray, 0.5 Milligram/Spray, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Summary
The Food and Drug Administration (FDA, Agency, or we) has determined that NASCOBAL (cyanocobalamin) nasal spray, 0.5 milligram (mg)/spray, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The FDA's determination that NASCOBAL is not withdrawn for safety or effectiveness allows ongoing approval of abbreviated new drug applications (ANDAs), facilitating market entry of generics. This impacts business owners in pharmaceuticals by indicating a stable market for generic products based on this formulation.