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Regulatory and Washington

  • Warner Chilcott settles with Zydus over generic Asacol HD

    DUBLIN — A subsidiary of Actavis has reached a settlement with a generic drug maker that will allow the launch of a generic version of a treatment for ulcerative colitis in 2015.

    Actavis said its Warner Chilcott subsidiary had settled with Zydus Pharmaceuticals USA and Cadila Healthcare over Zydus' generic version of Asacol HD (mesalamine) delayed-release tablets.

  • Lawsuit challenges Calif. Medicaid reimbursement cuts

    SACRAMENTO, Calif. — Reimbursement cuts to California's state Medicaid program are the subject of a lawsuit filed last week in San Francisco.

    The Professional Pharmacy Alliance and the California Korean American Pharmacists Association filed suit against the California Department of Health Care Services in San Francisco Superior Court over an across-the-board 10% cut in 2011 to the reimbursement rates for most providers under the program, known as Medi-Cal.

  • FDA approves generic versions of Cymbalta

    SILVER SPRING, Md. – The Food and Drug Administration has approved the first generic versions of a drug used to treat depression and other conditions, the agency said Wednesday.

    The FDA announced the approval of generic duloxetine delayed-release capsules manufactured by Aurobindo Pharma, Dr. Reddy's Labs, Lupin, Sun Pharmaceutical Industries, Teva Pharmaceutical Industries and Torrent Pharmaceuticals.

  • FDA seeks to limit use of antibiotics in animal feed to curb rise of resistant bacteria

    SILVER SPRING, Md. – The Food and Drug Administration is planning to limit the use of antimicrobials in food animals in an effort to stem the rise of antibiotic-resistant bacteria, the agency said Wednesday.

  • Reports: New York Board of Health votes unanimously to require flu vaccination for children in day care, preschool

    NEW YORK — All children attending day care or preschool in New York must get a flu vaccine by the end of the year, according to published reports.

    CBS News reported that the city's Board of Health voted unanimously Wednesday to require all children younger than 5 attending a day care or preschool to receive the vaccine before Dec. 31.

  • Tennessee politicians and CHPA expand statewide Anti-Smurfing Campaign

    KINGSPORT, Tenn. — Lt. Gov. Ron Ramsey, Tennessee Rep. Tony Shipley, R-Kingsport along with representatives from Food City and the Consumer Healthcare Products Association, on Monday announced the expansion of Tennessee's statewide Anti-Smurfing Campaign.  

  • FDA advisory committee recommends approval for Takeda's vedolizumab

    DEERFIELD, Ill. — An expert panel at the Food and Drug Administration has given a thumbs-up to an experimental drug made by Takeda Pharmaceutical Co. for treating ulcerative colitis and Crohn's disease, the drug maker said.

  • Study: Despite understanding flu's seriousness, misconceptions remain

    BETHESDA, Md. — Only a quarter of respondents to a new survey would call a doctor for advice when someone at home has the flu, despite widespread recognition of it as serious and of the need for vaccination.

    The study, conducted by the National Foundation of Infectious Diseases, found that 93% of adults understand the flu is serious, while 87% understand it's highly contagious, and 66% understand the need for vaccination. The study included a national survey of 1,000 adults and surveys of 500 adults in 10 states, collected between Aug. 6 and Aug. 28.

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