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Regulatory and Washington

  • GPhA applauds new IMS Institute report

    WASHINGTON — The main trade group for the generic drug industry is heralding a new cost analysis by the IMS Institute for Healthcare Informatics showing that generic drugs can reduce co-payments by up to 80%.

    According to the analysis, contained in the report “The Use of Medicines in the United States: Review of 2010,” the average co-payment for a generic drug was $6.06 per prescripton last year, compared with $23.65 to $34.77 for preferred and nonpreferred brand drugs.

  • BIO's Rosado joins FMI

    ARLINGTON, Va. — The Food Marketing Institute said Tuesday that it has appointed Robert Rosado as director of government relations.

    According to FMI, Rosado will focus on legislation that impacts supermarkets in the areas of food safety, health care, food deserts and the 2012 Farm Bill.

    “Rob has a broad range of expertise in food and agriculture that will be very helpful to FMI and its members. His background also includes working with federal agencies on many issues related to the food retail industry,” FMI president and CEO Leslie Sarasin said.

  • NACDS launches mobile app for Annual Meeting

    ALEXANDRIA, Va. — The National Association of Chain Drug Stores announced on Tuesday the launch of its 2011 Annual Meeting mobile Web-based application, which is designed to enhance attendees' efficiency and experience at the NACDS Annual Meeting from April 30 to May 3 in Scottsdale, Ariz.

    In addition, the NACDS mobile website, m.NACDS.org, has been updated with information about the Annual Meeting and all 2011 NACDS events.

  • Sigma-Tau OKed to manufacture primary ingredient in Oncaspar

    GAITHERSBURG, Md. — The Food and Drug Administration has given approval to Sigma-Tau Pharmaceuticals to manufacture the main ingredient of a treatment for leukemia, the drug maker said.

    Sigma-Tau was approved to manufacture L-asparaginase, the primary ingredient in the drug Oncaspar (pegaspargase). Sigma-Tau began seeking approval when the previous manufacturer ceased production. The drug is used to treat acute lymphoblastic leukemia, also known as ALL.

  • Forest purchases rights to azimilide

    NEW YORK — Drug maker Forest Labs has acquired worldwide rights to a drug developed by Procter & Gamble Pharmaceuticals for treating arrhythmia.

    Forest said Tuesday that it had purchased the rights to azimilide from Blue Ash Therapeutics and had been assigned a license agreement between Blue Ash and Warner Chilcott. Forest will assume responsibility for all future development and commercialization, including costs. Financial terms of the deal were not disclosed.

  • Taro receives FDA approval for generic Aldara

    HAWTHORNE, N.Y. — The Food and Drug Administration has approved a topical treatment for skin conditions made by Israeli generic drug maker Taro Pharmaceutical Industries.

    Taro announced Monday the approval of imiquimod cream in the 5% strength. The drug is used to treat actinic keratosis and external genital warts, and is a generic version of Graceway Pharmaceuticals’ Aldara.

    Imiquimod cream has annual sales of around $340 million in the United States, according to Taro.

  • Lilly receives complete response letter for liprotamase

    INDIANAPOLIS — The Food and Drug Administration declined to approve a drug made by Eli Lilly for treating a disease of the pancreas that often occurs in patients with cystic fibrosis, Lilly said.

  • Report: Kansas makes switch to NPLEx system to track pseudoephedrine sales

    TOPEKA, Kansas — Kansas on Monday officially made the move from a paper tracking system for pseudoephedrine sales to the electronic tracking capabilities afforded through the National Precursor Log Exchange, according to an Associated Press report published Monday. Kansas first announced its intent to switch over to NPLEx in March 2010.

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