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  • FDA grants priority review to J&J heart drug

    RARITAN, N.J. — The Food and Drug Administration has given priority review to a regulatory application from Johnson & Johnson for a drug designed to reduce the risk of complications from internal blood clots.

    J&J's Janssen Research & Development division announced that the FDA had given the designation to Xarelto (rivaroxaban), an oral anticoagulant, to reduce the risk of certain types of heart attacks in patients with acute coronary syndrome, which 1.2 million Americans are diagnosed with every year.

  • FDA exploring how to expand eligible Rx-to-OTC switches by utilizing pharmacy

    SILVER SPRING, Md. — The Food and Drug Administration on Tuesday announced it will hold a public hearing on March 22 and 23 to discuss how technology can expand which drug products can be switched from prescription to over-the-counter status.

  • Report: GSK recalls blood-pressure drug made at Novartis plant

    NEW YORK — GlaxoSmithKline has recalled nearly 400,000 bottles of a hypertension drug that were distributed in the United States, according to published reports.

    Reuters Health reported that GSK was recalling 394,230 bottles of its DynaCirc CR after the drug's manufacturer, Novartis, reported inconsistent packaging practices. The generic drug is manufactured at a Novartis plant in Lincoln, Neb.

    No adverse events were reported, GSK was quoted as saying, but the drug maker elected to put forth a recall as a precautionary measure.

  • Statins could increase blood sugar, cause cognitive problems, FDA says

    SILVER SPRING, Md. — Drugs widely used to treat cholesterol may cause increases in blood sugar and other symptoms, the Food and Drug Administration said Tuesday.

  • FDA declines to approve Watson reproductive drug

    PARSIPPANY, N.J. — The Food and Drug Administration turned down an application for a topical reproductive drug made by Watson Pharmaceuticals and Columbia Labs, the two companies said Monday.

  • FDA committee recommends approval for obesity drug

    MOUNTAIN VIEW, Calif. — A panel of experts at the Food and Drug Administration has recommended approval for an obesity drug that so far had not met much success at the agency.

    Vivus announced Wednesday that the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 20-2 in favor of approving Qnexa (phentermine and topiramate) for obesity in adults. The FDA is not bound by advisory committee votes when it decides whether or not to approve a drug, but usually follows them.

  • FDA accepts NDA filing for Impax's Parkinson's disease treatment

    HAYWARD, Calif. — The Food and Drug Administration has accepted a new drug application for the treatment of idiopathic Parkinson’s disease.

    Impax Pharmaceuticals, the branded products division of Impax Labs, said it filed its NDA for the investigational drug IPX066, an extended-release capsule formulation of carbidopa-levodopa, for review in December 2011. IPX066 has been licensed to GlaxoSmithKline for countries outside the United States and Taiwan for development and marketing.

  • Novartis to pay $440 million for hepatitis C drug

    WATERTOWN, Mass. — Novartis plans to pay up to $440 million for rights to a drug for treating hepatitis C made by Enanta Pharmaceuticals, Enanta said.

    Enanta said it had made a licensing agreement with the Swiss drug maker for the worldwide development, manufacturing and commercialization of the drug EDP-239, which works by inhibiting NS5A, a protein that is key to the virus' replication.

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