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Biovail has filed a lawsuit against the FDA and is asking a federal court to reverse an agency decision approving the marketing of a generic version of its antidepressant drug, Wellbutrin XL.
The FDA is pledging to continue fighting an effort by wholesalers to stop the agency from implementing its drug-tracking rule, despite early setbacks in court.
Pfizer’s inhalable insulin product Exubera will stay on the market while a court considers whether the company infringed on Novo Nordisk’s patents, a U.S. district judge ruled.
The U.S. District Court for the Southern District of New York did not “abuse its discretion” in granting a preliminary injunction against Apotex blocking further sales of its generic Plavix pending the outcome of the patent challenge, a federal appeals court determined.
Trey Sunderland, a senior scientist at the National Institute of Mental Health (NIMH), pleaded guilty to participating in a conflict of interest by accepting $285,000 in consulting fees from Pfizer.
The FDA’s case for implementing its drug-tracking rule just became more difficult as a federal court has seemingly undercut one of the government’s central arguments against a stay on the rule, an industry official says.
Armed with several production and method-of-use patents covering its cancer drug Thalomid, Celgene is preparing a legal challenge to head off Barr Laboratories’ move to market thalidomide, a generic version of the drug, company executives said.
The U.S. District Court for the District of New Jersey has vacated an earlier ruling that blocked generic producers Sandoz Pharmaceuticals and Upsher-Smith Laboratories from marketing their newly approved oxandrolone product, a generic version of Savient Pharmaceutical’s Oxandrin.