Generic Drug Approval
/ˈdʒɛnərɪk drʌg əˈpruːvəl/
Definitions
- (n.) The regulatory process by which a generic drug is officially authorized for sale and use, confirming it meets standards of safety, efficacy, and equivalence to the brand-name counterpart.
The company received generic drug approval from the FDA after demonstrating bioequivalence to the original medication.
Forms
- generic drug approval
Related terms
See also
Commentary
Typically involves submission of an Abbreviated New Drug Application (ANDA) demonstrating bioequivalence; important for expanding market competition and lowering drug costs.
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