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Unapproved New Drugs

Meaning

Unapproved New Drugs, in the United States regulatory context, are pharmaceutical agents that have not received the necessary approval from the Food and Drug Administration (FDA) for marketing and sale, typically because they lack an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). These products are considered illegal to distribute and sell for therapeutic use because their safety, efficacy, and manufacturing quality have not been scientifically substantiated and reviewed by the agency. The use of such drugs in hormonal health poses significant, unquantified risks to patient well-being.