ANDA (Abbreviated New Drug Application)

An Abbreviated New Drug Application (ANDA) is a process used in the United States for a pharmaceutical company to seek approval to market a generic version of an already approved brand-name drug. Instead of conducting extensive clinical trials, the ANDA demonstrates that the generic drug is chemically identical and performs the same as the original in terms of safety, effectiveness, and quality. This allows for increased competition in the market and often leads to lower prices for consumers. The FDA reviews the ANDA to ensure it meets required standards before granting approval.