Abbreviated New Drug Applications (ANDAS): Future Trend in Radiopharmaceuticals

Abstract

The Drug Price Competition and Patent Term Restoration Act of 1984 (commonly called the Waxman Hatch Amendments of 1984, to the Federal Food, Drug, and Cosmetic Act) provided for a major expansion of the new drugs eligible for abbreviated applications. As long as the conditions specified in the Code of Federal Regulations (CFR) Title 21, subsection 312.55 are met, reports of nonclinical laboratory studies (except those pertaining to in vivo bioavailability of the drug product), and clinical investigations can be omitted. New drugs approved under these regulations are so called generic drugs as opposed to listed or pioneer (innovator) drugs. As the patents on more and more radiopharmaceuticals reach their expiration, the radiopharmaceutical industry is likely to produce more of these generic versions of innovator drugs. The ANDAs are required to contain information required under subsections 314.50 (a), (b), (d)(1) and (3), (e), and (g). The applicant must provide satisfactory information on the composition, manufacture and control of the drug substance (active ingredient) as well as on the final drug product to satisfy the Food and Drug Administration (FDA) requirements that the generic new drug be safe and bio-equivalent to the listed new drug.