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Generic firm Apotex said its version of GlaxoSmithKline’s antidepressant Paxil (paroxetine HCl) garnered sales of about $150 million to $200 million during its 180-day exclusivity period — a return far smaller than what it had expected because of an authorized generic competitor.
The FDA appears to be adopting a less paternalistic approach to regulating direct-to-consumer (DTC) advertising, according to FTC Commissioner Thomas Leary.
Representatives of the drug industry pounded the HHS Task Force on Drug Importation yesterday with their contention that it is impossible to ensure that imported drugs are safe and effective.
Roche has said it will not enforce patents on its drug products sold in the world's least developed countries -- a move that frees generic firms to supply those markets.
The FDA has broken its silence on Part 11 for the first time since issuing a guidance last August by calling on industry to comment on how to make Part 11 "less prescriptive," either by revising the rule or issuing additional guidance documents.
Despite public pronouncements that the FDA will prosecute health plans that cover the cost of drugs bought outside the U.S., the agency allegedly is saying the opposite to insurers behind closed doors.
The FDA’s final rule banning dietary supplements containing ephedra due to safety concerns went into effect yesterday despite last-minute legal maneuvering by two manufacturers.
After waiting more than three months for the FDA to decide whether to let Illinois start a pilot program to reimport drugs from Canada, Democratic Gov. Rod Blagojevich has asked the agency to implement a nationwide Canadian reimportation program — threatening a lawsuit if the FDA doesn’t respond by October.
The FDA has some authority under federal law that it may not be using that could allow the agency to require dietary supplement makers to file all known safety data before marketing a new compound, according to a new report from the Institute of Medicine and the National Research Council of the National Academies.