Johnson Matthey methylphenidate production subject of appeals court case brought by M.D. Pharma.
Executive Summary
JOHNSON MATTHEY METHYLPHENIDATE PRODUCTION SUBJECT OF COURT REVIEW: oral arguments were heard in MD Pharmaceutical v. Drug Enforcement Administration Dec. 4 before a three-judge panel of the D.C. federal appeals court. MD Pharmaceutical is seeking to rescind a DEA order granting registration of Johnson Matthey as a manufacturer of the Schedule II controlled substance methylphenidate, the active ingredient in Ciba-Geigy's Ritalin. The Medeva subsidiary argues that the decision to register Johnson Matthey was "unsupported by substantial evidence, in face of the company's knowing and repeated violations" of the Controlled Substances Act and DEA regulations. Johnson Matthey intervened into the case but did not present oral arguments.
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