The FDA approves generic drugs through a specific process. Drug companies must submit an abbreviated new drug application (called ANDA) for approval to market a generic product. The ANDA process does not require the generic drug company to repeat animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness. However, the generic drug company must provide proof of bioequivalence.
To gain FDA approval, a generic drug must:
- contain the same active ingredient(s) as the brand drug (inactive ingredients such as fillers and dyes may vary)
- be identical in strength, dosage form, and route of administration
- have the same use indications
- be bioequivalent
- meet the same batch requirements for identity, strength, purity, and quality
- be manufactured under the same strict standards of FDA’s good manufacturing practice regulations required for brand products
