A drug product sold under the provisions of Section 505(j) of the Federal Food, Drug and Cosmetic Act. The Abbreviated New Drug Application (ANDA) was enabled through the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman). The ANDA must contain (1) information to show conditions of the proposed generic drug's labeling have been previously approved for the "reference listed drug" (RLD), (2) that the generic drug is pharmaceutically equivalent to the RLD (same active ingredient, route of administration, dosage form and strength), (3) that the generic drug is bioequivalent to the RLD, (4) the generic drug must have the same labeling as the RLD, and (5) the generic drug must be manufactured in compliance with cGMPs. Finally, with regard to patents, the sponsor of a generic drug application must certify to the FDA that (I) information on any patents were not filed by the NDA holder with FDA, (II) relevant patent(s) have expired, (III) relevant patent(s) will expire on some future date, or (IV) relevant patent(s) are invalid or would not be infringed by the manufacture of a generic version.
blog comments powered by Disqus