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Regulatory and Washington

  • CDC, CHPA partner on medicine safety education initiative

    WASHINGTON — The Centers for Disease Control and Prevention and the Consumer Healthcare Products Association Educational Foundation on Tuesday launched the Up and Away and Out of Sight educational program to help educate parents on the importance of keeping their medicines in a safe place from children. In recent years, the number of accidental overdoses in children increased by 20%, the agency and association stated.

  • NACDS aims to set record straight regarding PBM testimony at Senate hearing

    ALEXANDRIA, Va. — The National Association of Chain Drug Stores on Wednesday challenged some of Express Scripts' and Medco's testimony during last week's hearing before the Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights, most notably that PBMs are subject to state regulation in all states and that as a PBM the two companies have no influence on the design of prescription drug benefits.

  • HHS, Novartis celebrate opening of state-of-the-art, stateside vaccine facility

    WASHINGTON — The Department of Health and Human Services on Monday announced that the first U.S. facility to use a faster and more flexible technology to make influenza vaccine was dedicated as part of an initiative that could provide vaccine supplies sooner in an influenza pandemic.

  • FTC approves Valeant's acquisitions of Dermik, Ortho Dermatologics

    MISSISSAUGA, Ontario — The Federal Trade Commission has voted to approve Valeant's acquisitions of Dermik, a unit of French drug maker Sanofi that makes drugs for skin conditions, and Ortho Dermatologics, a division of Johnson & Johnson that also makes skin drugs.

  • Report: New Wash. law cuts off patient access to painkillers

    NEW YORK — A new law in Washington state intended to curb accidental deaths related to opioid painkillers is having some adverse side effects, according to published reports.

  • Reports: N.Y. Gov. Cuomo signs controversial mail-order pharmacy bill

    NEW YORK — New York state Gov. Andrew Cuomo has signed into law a bill that would forbid health insurers from requiring plan members to order prescription drugs from mail-order pharmacies, according to published reports. 

  • FDA releases draft of GDUFA goals

    WASHINGTON — Following months of meetings and negotiations with the drug and chemical industries, the Food and Drug Administration has released a draft of the goals of the Generic Drug User Fee Act.

  • FDA approves painkiller made by Sun Pharmaceutical Industries

    MUMBAI, India — The Food and Drug Administration has approved a generic painkiller made by Sun Pharmaceutical Industries, Sun said.

    Sun announced the approval of tramadol hydrochloride extended-release tablets, a generic version of Valeant International's Ultram ER. The drug is used to treat moderate to moderately severe chronic pain in adults who need constant treatment for an extended period of time.

    Various versions of the drug have annual sales of $125 million, according to Sun.

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