Policy on 180-Day Marketing Exclusivity for Drugs Marketed Under Abbreviated New Drug Applications; Clarification
fda-drug · Food and Drug Administration · Rule · Published 1997-11-28 · 62 FR 63268
Document
Document number
97-31150
Federal Register citation
62 FR 63268
CFR reference
21 CFR 314
Type
Rule
Action
Clarification.
Category
fda-drug
Sub-agency
Food and Drug Administration
Publication date
1997-11-28
HHS docket
Docket No. 85N-0214
Abstract
The Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) is publishing this document to clarify the status of its practices governing 180 days of marketing exclusivity for generic drugs and the approval of abbreviated new drug applications (ANDA's) subject to patent litigation. This document is being published due to recent court decisions interpreting provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments).