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  • GSK to pay legal charge relating to Avandia

    LONDON — Drug maker GlaxoSmithKline will take a legal charge of $3.4 billion related to its promotion of a controversial diabetes drug.

    The British company said the charge related to an investigation by the U.S. Attorney’s Office for the District of Colorado regarding sales and promotion of the drug Avandia (rosiglitazone) in spite of reports of the risk of heart attacks in patients taking it.

  • Court: Teva, Barr Labs must hold off on generic versions of Sensipar

    THOUSAND OAKS, Calif. — Generic drug maker Teva Pharmaceutical Industries and subsidiary Barr Labs are prohibited from marketing a generic version of an Amgen drug for patients with chronic kidney disease until the drug’s patents expire, under a recent court decision.

  • Takeda, Zinfandel form partnership

    OSAKA, Japan — Japanese drug maker Takeda Pharmaceutical  has signed an agreement with Durham, N.C.-based Zinfandel Pharmaceuticals to develop a test for assessing Alzheimer’s disease risk in adults, the two companies said.

  • FDA panel votes against Lilly's EPI treatment

    INDIANAPOLIS — An advisory committee of the Food and Drug Administration voted last week not to recommend approval of a drug from Eli Lilly.

    The FDA Gastrointestinal Drugs Advisory Committee said it recommended that additional studies be conducted prior to the FDA's review of liprotamase, a nonporcine pancreatic enzyme replacement therapy, for the treatment of exocrine pancreatic insufficiency. EPI is a disease resulting from cystic fibrosis, removal of the pancreas, chronic pancreatitis and other conditions.

  • Genentech: Despite alcohol prep pads recall, drugs are safe to use

    SOUTH SAN FRANCISCO, Calif. — Biotech company Genentech advised consumers to avoid alcohol prep pads distributed with some of its drugs due to possible contamination.

    Genentech, a subsidiary of Swiss drug maker Roche, said users of its drugs should not use prep pads made by Triad Group, but that the drugs themselves were still safe to use. Triad Group recently recalled several of its pads due to contamination, prompting Bayer HealthCare to issue a similar warning.

  • Cumberland gets FDA OK for Acetadote formulation

    NASHVILLE, Tenn. — The Food and Drug Administration has approved a new formulation of a drug for treating acetaminophen poisoning.

    Cumberland Pharmaceuticals announced Thursday that the agency had approved a version of Acetadote (acetylcysteine) injection that does not contain preservatives or stabilization and chelating agents, and will replace the currently marketed version. The drug originally was approved in 2004.

  • FDA warns consumers of liver injury risk when taking Multaq

    SILVER SPRING, Md. — The Food and Drug Administration and drug maker Sanofi-Aventis are warning healthcare professionals and patients about the possibility of severe liver injury in patients taking a Sanofi heart drug.

  • K-V: FDA will approve Gestiva by PDUFA date

    ST. LOUIS — K-V Pharmaceutical announced Wednesday that the Food and Drug Administration extended its Prescription Drug User Fee Act action date to April 13 for a drug under development for preventing preterm birth.

    K-V, which acquired the injected drug Gestiva (hydroxyprogesterone caproate) from Hologic in 2008, said Hologic originally had been told the FDA would take action Thursday.

    K-V said it was confident the drug would receive approval and that the FDA would take action on or before the new PDUFA date.

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