Generic Drug Approval

Drug companies must submit an abbreviated new drug application (ANDA) for approval to market a generic product. The Drug Price Competition and Patent Term Restoration Act of 1984, more commonly known as the Hatch-Waxman Act, made ANDAs possible by creating a compromise in the drug industry. Generic drug companies gained greater access to the market for prescription drugs, and innovator companies gained restoration of patent life of their products lost during FDA's approval process.

New drugs, like other new products, are developed under patent protection. The patent protects the investment in the drug's development by giving the company the sole right to sell the drug while the patent is in effect. When patents or other periods of exclusivity expire, manufacturers can apply to the FDA to sell generic versions.

The ANDA process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness. This applies to drugs first marketed after 1962.

To gain FDA approval, a generic drug must:

• contain the same active ingredients as the innovator drug(inactive ingredients 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 innovator products