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Regulatory and Washington

  • Reports: Takeda sues Amneal over generic version of Colcrys

    NEW YORK — Generic drug maker Amneal Pharmaceuticals is seeking Food and Drug Administration approval for a gout drug, prompting a lawsuit from the maker of the branded version, according to published reports.

    Law360 reported that Takeda Pharmaceuticals USA had sued Amneal in the U.S. District Court for the District of Delaware over the drug Colcrys (colchicine), used to treat gout and familial Mediterranean fever.

  • FDA approves Lundbeck's Sabril in children

    DEERFIELD, Ill. — The Food and Drug Administration has approved a drug made by Lundbeck for treating a form of epilepsy in children, the drug maker said.

    Lundbeck announced the approval of Sabril (vigabatrin) as an add-on therapy for refractory complex partial seizures in children ages 10 years and older who have not responded adequately to other treatments, as long as the benefit of treatment outweighs the risk of vision loss. The drug was already approved for treating the same condition in adults in 2009.

  • BIO calls for different names for biosimilars, branded biotech drugs

    NEW YORK — In what is emerging as the latest battle over follow-on biologics, a new argument has emerged about what to call them, and supporters of biotechnology companies are the latest to take a shot.

  • FDA introduces e-learning program about untruthful, misleading drug ads

    SILVER SPRING, Md. — The Food and Drug Administration has launched an online learning course aimed at healthcare professionals to educate them about potentially untruthful or misleading drug ads and promotional materials.

  • Drug take-back programs draw praise

    WASHINGTON — The last six drug take-back days sponsored by the Drug Enforcement Agency have collected nearly 2.8 million pounds of prescription drugs at more than 5,800 sites across the country, drawing praise from a drug industry trade organization.

    The Generic Pharmaceutical Association said it "strongly supports" the DEA's efforts, including the seventh annual National Prescription Drug Take-Back Day, which took place Saturday.

  • FDA to recommend rescheduling of opioid painkiller hydrocodone from CIII to CII

    SILVER SPRING, Md. — The Food and Drug Administration plans to recommend stronger regulations for a commonly used opioid painkiller.

  • Accreditation Council for Pharmacy Education to work with francophone counterpart on pharmacy education standards

    CHICAGO — The Accreditation Council for Pharmacy Education has established a memorandum of understanding with an organization of French-speaking pharmacy school deans and educators to cooperate and collaborate to advance the quality of pharmacy education around the world.

  • APhA, NACDS, NCPA join biosimilar naming debate

    NEW YORK — Three pharmacy groups are petitioning the World Health Organization to uphold common generic names for biosimilars and their branded reference products.

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