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Regulatory and Washington

  • FDA approves Elite Pharmaceuticals' opioid painkiller

    NORTHVALE, N.J. — The Food and Drug Administration has approved a regulatory approval application from Elite Pharmaceuticals for an opioid painkiller, the drug maker said Wednesday.

    Elite announced the FDA approval of its supplemental application for the manufacture and packaging of naltrexone hydrochloride tablets in the 50-mg strength. The company said the approval would allow it to start manufacturing and packaging the drug for its sales and marketing partner, Mikah Pharma, from which it bought rights to the drug in September 2010.

  • WHO updates consumption guidelines for salt, potassium

    GENEVA — Adults should consume less than 2,000 mg of sodium, or 5 grams of salt, and at least 3,510 mg of potassium per day, according to new guidelines issued by the World Health Organization last week. A person with either elevated sodium levels and low potassium levels could be at risk of raised blood pressure which increases the risk of heart disease and stroke.

    Currently, most people consume too much sodium and not enough potassium.

  • FDA approves Sandoz antibiotic

    PRINCETON, N.J. — The Food and Drug Administration has approved a generic antibiotic made by Sandoz, the drug maker said Wednesday.

    Sandoz, the generics arm of Swiss drug maker Novartis, announced the approval and launch of clindamycin in 5% dextrose in minibag form, the first generic version of Pfizer's Cleocin Phosphate in Dextrose 5%.

    Sales of the branded version were $52.2 million in 2012, according to IMS Health.

  • JAMA report criticizing calcium supplementation in men raises eyebrows among supplement associations

    CHICAGO — A JAMA report released Monday afternoon that suggested a high intake of supplemental calcium is associated with an increased risk of cardiovascular disease death in men was criticized by several dietary supplement agencies for being inconclusive. According to the Council for Responsible Nutrition's most recent survey of U.S. adults, 17% indicated they take a calcium supplement.

  • NCPA to FDA: Rescheduling hydrocodone combo products to create headache for legitimate pain patients

    ALEXANDRIA, Va. — The National Community Pharmacists Association on Monday submitted comments to the Food and Drug Administration urging the agency to preserve access to hydrocodone-containing pain relief products, as FDA considers moving the medications from the Drug Enforcement Administration’s Schedule III list of controlled substances to the more restrictive Schedule II list.

  • Report documents opportunities, challenges for biosimilars

    NEW YORK — A new report sheds light on some of the opportunities and challenges that exist in follow-on biologics, arguing that their opportunity to generate value depends on factors like the speed of development, clarity of regulation, ease of access and the roles of all stakeholders.

  • FDA approves Perrigo testosterone gel

    ALLEGAN, Mich. — The Food and Drug Administration has approved a testosterone gel product made by Perrigo, the drug maker said Tuesday.

    Perrigo announced the approval of the testosterone gel in the 1% strength for the treatment of men with low or no testosterone.

    The drug is bioequivalent to AbbVie's AndroGel, which has annual sales of about $705 million, according to Symphony Health.

  • 'Look ahead and be bold,' Anderson urges NACDS members as group marks 80th year

    FORT LAUDERDALE, Fla. — National Association of Chain Drug Stores president and CEO Steve Anderson pledged to be proactive in advocating for pharmacy in the organization's 80th year.

    Speaking at the NACDS' Regional Chain Conference Monday, Anderson said pharmacy stood at an "inflection point," with many more on the horizon.

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