FDA Rules NASCOBAL Discontinued Voluntarily, Not Due to Safety or Effectiveness Concerns
April 09, 2025
April 09, 2025
WASHINGTON, April 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has confirmed that NASCOBAL (cyanocobalamin) nasal spray, 0.5 mg per spray, was not removed from the market due to safety or efficacy concerns.
This ruling, issued on April 9, 2025, enables the agency to continue approving abbreviated new drug applications (ANDAs) that reference NASCOBAL, as long as those applications meet existing legal and regulatory standards. The product . . .
This ruling, issued on April 9, 2025, enables the agency to continue approving abbreviated new drug applications (ANDAs) that reference NASCOBAL, as long as those applications meet existing legal and regulatory standards. The product . . .