Searle Daypro protected from ANDAs until October 1999 by provision in 1996 budget act.
SEARLE DAYPRO PROTECTED FROM ANDAs UNTIL OCT. 29, 1999 under language included in the 1996 budget agreement (HR 3019) signed into law April 26. The legislation prohibits generic manufacturers from filing an ANDA for Searle's nonsteroidal anti-inflammatory agent Daypro (oxaprozin) until the two-year exclusivity extension expires.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth