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Regulatory and Washington

  • Federal court rules in favor of Actavis in generic asthma drug case

    PARSIPPANY, N.J. — A court has ruled in favor of generic drug maker Actavis concerning its generic version of a drug to treat asthma in children, the company said.

  • FDA approves new Teva contraceptive

    JERUSALEM — The Food and Drug Administration has approved a new contraceptive therapy made by Teva Pharmaceutical Industries, Teva said Monday.

    The drug maker announced the approval of Quartette (levonorgestrel, ethinyl estradiol and ethinyl estradiol) tablets. Teva said the drug represented the "next generation" of extended-regimen oral contraceptives and was designed to minimize breakthrough bleeding between scheduled periods.

  • GSK Consumer Healthcare commends FDA nicotine replacement therapy proposals

    PARSIPPANY, N.J. — GlaxoSmithKline Consumer Healthcare today commended the proposals by the U.S. Food and Drug Administration after the administration announced recommendations to remove certain warning statements and modifications of the instructions for use of nicotine replacement therapy products.

    According to the statement released by GSK Consumer Healthcare:

  • Actavis seeks approval for additional strength of generic testosterone gel

    PARSIPPANY, N.J. — Just a week after the Supreme Court heard the Federal Trade Commission's lawsuit over its deal with AbbVie to sell a generic version of a testosterone-replacement therapy, Actavis is challenging the patent on another strength of the drug.

    Actavis said Monday that it had filed with the Food and Drug Administration for approval of testosterone gel in the 1.62% strength. The drug is a generic version of AbbVie's AndroGel 1.62%. The case that went before the Supreme Court on March 25 concerns the 1% strength of AndroGel.

  • Walgreens to expand solar energy initiative in Colorado

    AURORA, Colo. — A Colorado-based firm will install solar power systems at 22 Walgreens stores in 14 cities in the state over the next few months, under a partnership between the two companies.

    Walgreens announced Monday an expansion of its relationship with SolarCity, saying the new power systems would reduce more than 47.5 million pounds of carbon dioxide emissions over the next two decades.

  • Winners of contest to spur interest in pharmacy, STEM careers for high school students announced

    WASHINGTON — Three high school seniors from Topeka, Kan., won a contest that sponsors hope will lead to better health outcomes while also getting young people interested in pharmacy careers.

  • FDA proposes regulations for meetings between agency, biosimilar makers

    SILVER SPRING, Md. — The Food and Drug Administration is seeking comment from drug makers and others concerning formal meetings between the agency and companies looking to market follow-on biologics.

  • Medicare dashboard advances ACA goals for chronic conditions

    WASHINGTON — A new Medicare Chronic Conditions Dashboard announced today by Marilyn Tavenner, acting administrator of the Centers for Medicare and Medicaid Services (CMS), furthers the Patient Protection and Affordable Care Act’s goals for health promotion and the prevention and management of multiple chronic conditions.

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