Mylan intervenes to reverse federal court ruling preventing generic terfenadine; patent `129 at issue.
Executive Summary
MYLAN INTERVENES IN MMD v. KESSLER TERFENADINE CASE OVER PATENT `129 to protect the company's investment in a generic product to compete with what is now Hoechst Marion Roussel's nonsedating prescription antihistamine Seldane, according to papers filed with the D.C. federal court Sept. 29. Judge Royce Lamberth ruled Sept. 19 in favor of Hoechst, granting the company's motions for summary judgment and a preliminary injunction that prohibits FDA from approving any ANDAs for a generic form of terfenadine that does not include certification for patent #4,254,129.
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