An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA s Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Generic drug applications are called abbreviated because they are generally not required to include pre-clinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, a generic applicant must demonstrate scientifically that its product is bioequivalent (i.e., performs in the same manner as the innovator drug). Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low-cost alternative to the American public (text from www.fda.gov/cder/drugsatfda/Glossary.htm).

Acronym for the parameters used to understand drug behavior in a living system: absorption, distribution (among the tissues), metabolism, excretion, and toxicology.

A nucleic acid sequence that is complementary to the coding sequence of DNA or mRNA.

The active pharmaceutical ingredient in a drug (biological or synthetic chemical): any substance or mixture of substances intended to be used in the manufacture of a drug product and that, when used in the production of a drug, becomes an active ingredient in the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body as defined by the...