Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA) An abbreviated new drug application (ANDA) contains information that is submitted to the FDA for examination and possible approval of a generic drug product. Once approved, an application may produce and promote the generic drug product as a safe, effective, and less expensive alternative to the brand-name drug it references. Generic drug applications are referred to as "abbreviated" since they are typically not required to include preclinical (animal) and clinical (human) evidence to show safety and effectiveness. Key points about ANDAs: Bioequivalence: Generic medicinal products approved through ANDA must be bioequivalent, which means they are absorbed into the bloodstream at the same rate and extent as the brand-name drug. Cost Savings: Generic drugs approved through the ANDA process are often less expensive than their brand-name counterparts, increasing affordability and access to important medications. Exclusivity Period: Generi...