In Brief: Generic ranitidine
Executive Summary
Generic ranitidine: Appeals court will hold emergency hearing July 22 to reconsider July 9 injunction preventing FDA from approving Novopharm's ANDA in time for a July 10 launch ("The Pink Sheet" July 14, T&G-1). Should the stay remain in place, the earliest FDA could theoretically approve a ranitidine ANDA would be Aug. 29 -- the date it determined Genpharm's generic exclusivity period will expire -- unless Genpharm resolves the patent suit brought by Glaxo or licenses its exclusivity to another firm with tentative approval...
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
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 Skin Infections Guidance Spurs Debate On Endpoint Relevance
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
Shire Hopes To Sow Future Deals With $50M Venture Fund
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