Effective Date of Approval of an Abbreviated New Drug Application
fda-drug · Food and Drug Administration · Rule · Published 1998-11-05 · Effective 1998-11-10 · 63 FR 59710
Document
Document number
98-29610
Federal Register citation
63 FR 59710
CFR reference
21 CFR 314
Type
Rule
Action
Interim rule; opportunity for public comment.
Category
fda-drug
Sub-agency
Food and Drug Administration
Publication date
1998-11-05
Effective date
1998-11-10
HHS docket
Docket No. 85N-0214
Abstract
The Food and Drug Administration (FDA) is issuing an interim rule to amend its regulations establishing the effective date of approval of abbreviated new drug applications (ANDA's). The interim rule eliminates the requirement that an ANDA applicant successfully defend a patent infringement suit to be eligible for 180 days of marketing exclusivity.