Determination That MIACALCIN (Calcitonin Salmon) Injection, 100 USP Units/Milliliter (mL), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Issuing agencies
Abstract
The Food and Drug Administration (FDA, Agency, or we) has determined that MIACALCIN (calcitonin salmon) injection, 100 USP Units/ milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for calcitonin salmon injection, 100 USP Units/mL, if all other legal and regulatory requirements are met.
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