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Andrx’s plans to market a version of McNeil Consumer & Specialty Pharmaceuticals’ attention deficit/hyperactivity disorder (ADHD) drug Concerta could face new hurdles if the FDA accepts McNeil’s argument that additional studies are needed to establish bioequivalency.
The FDA decision to let generic firms omit food-related labeling information on King Pharmaceutical’s muscle relaxant Skelaxin (metaxalone) will render the generic alternatives less safe and effective than Skelaxin, according to King.
The Bush administration is requesting a net budget authority increase for the FDA next fiscal year that would boost agency funding by $108.8 million over fiscal 2004 approved appropriations, according to FDA acting Commissioner Lester Crawford.
Corixa has been ordered by the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) to immediately cease distribution of a promotional video for its combination cancer treatment and provide the agency with a plan of action to correct misleading safety and efficacy claims made in the video.
Contract manufacturer Andersen Pharmaceuticals needs to keep better track of its labeling and batch production records, the FDA determined following an inspection that uncovered four batch production record deficiencies at the firm's Norwich, N.Y., facility.
The FDA is calling on the makers of antidepressant drugs to add to their product labeling warnings that recommend closer monitoring of adult and pediatric patients who are treated with the drugs.
The hesitance of drugmakers to incorporate the latest scientific and technological advances into their manufacturing operations is contributing to the high cost of drug development and the recent decline in new molecular entities (NMEs) approved by the FDA, the agency said in a new report.