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U.S. Food and Drug Administration
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  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Drug and Biologic Approval and IND Activity Reports
  6. First Generic Drug Approvals
  7. ANDA (Generic) Drug Approvals - Previous Years
  1. First Generic Drug Approvals

ANDA (Generic) Drug Approvals - Previous Years

Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides the scientific and regulatory advice needed to bring safe, effective, high-quality generic alternatives to market, which in turn creates more affordable treatment options for patients.

“First generics” are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product in the United States. FDA considers first generics to be important to public health, and prioritizes review of these submissions.

First Generic Drug Approvals - Previous Years

 

ANDA (Generic) Drug Approvals - Previous Years

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