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Regulatory and Washington

  • FDA appeals preliminary injunction of new anti-smoking packaging graphics

    WASHINGTON — The Food and Drug Administration on Tuesday appealed a recent District Court ruling that had placed a preliminary injunction on new, graphic anti-smoking messages that were to be placed on cigarette packaging as of September 2012. The five tobacco company plaintiffs argued that the mandated graphics violate the First Amendment.

    The appeal moves the case to to the U.S. Court of Appeals for the D.C. Circuit.

  • Former President George W. Bush to deliver keynote at 2012 NACDS Annual Meeting

    ALEXANDRIA, Va. — Former President George W. Bush will serve as the keynote speaker at the annual meeting of the National Association of Chain Drug Stores in Palm Beach, Fla., NACDS announced.

  • Ranbaxy generic Lipitor launch delayed as Watson launches authorized generic

    NEW YORK — Ranbaxy Labs was supposed to launch its generic version of the world's top-selling drug Wednesday, but a competitor beat it to the punch as the former waits for final Food and Drug Administration clearance.

  • NCPA seeks to help community pharmacies boost front-end sales through new initiative

    ALEXANDRIA, Va. — In an effort to help community pharmacies to effectively compete in the marketplace, the National Community Pharmacists Association has launched an initiative that is designed to help these retailers create better business opportunities for front-end merchandise.

  • Walgreens and HHS dispense more than $10 million in flu shots to uninsured

    DEERFIELD, Ill. — Walgreens on Wednesday announced it is offering more than $10 million worth of free flu shot vouchers to Americans without health insurance coverage. The Department of Health and Human Services is assisting in the distribution of the vouchers in markets across the country.

  • NRF calls for sales tax fairness for brick-and-mortar, online retailers

    WASHINGTON — Internet retailers have an unfair advantage over Main Street merchants when it comes to sales tax, and legislation may be the solution to help level the playing field, according to the National Retail Federation.

  • Watson gets green light for generic Yaz

    PARSIPPANY, N.J. — Watson Pharmaceuticals subsidiary Watson Labs has received regulatory approval for a generic oral contraceptive.

    Watson Labs said its abbreviated new drug application for Vestura (3-mg drospirenone and 0.02-mg ethinyl estradiol) was approved by the Food and Drug Administration.

    Watson currently is involved in patent litigation with Bayer concerning the product, which is a generic version of Bayer's Yaz oral contraceptive product.

  • FDA accepts Eliquis for review

    NEW YORK and PRINCETON, N.J. — A drug designed to prevent stroke and systemic embolism in patients with atrial fibrillation has been accepted for review by the Food and Drug Administration.

    Bristol-Myers Squibb and Pfizer said their investigational compound Eliquis (apixaban) was accepted for review and granted a priority-review designation. The companies submitted the application to the agency after completing two phase-3 trials, which examined the efficacy and safety of Eliquis among about 24,000 patients.

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