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Regulatory and Washington

  • Reports: Court upholds Abilify patent

    NEW YORK — A generic version of a schizophrenia drug made by Otsuka Holdings and Bristol-Myers Squibb can't be launched until April 2015, according to published reports.

    Bloomberg reported that the U.S. Court of Appeals for the Federal Circuit upheld the validity of patents covering Abilify (aripiprazole) in the two companies' lawsuit against Teva Pharmaceutical Industries and Apotex.

    According to IMS Health, Abilify was the fourth top-selling drug in the United States in 2011, with sales of $5.2 billion.

  • NCPA seeks legislative relief to the business challenges faced by community pharmacy

    WASHINGTON — Community pharmacy operators are the "canary in the coal mine" when it comes to federal or state prescription programs, said Douglas Hoey, CEO for the National Community Pharmacists Association, during a press conference held Tuesday afternoon.

  • NACDS, NCPA urge Senate, House committees to preserve patient choice for Tricare beneficiaries

    ALEXANDRIA, Va. — The National Association of Chain Drug Stores and the National Community Pharmacists Association today expressed concerns in a letter sent to Senate Armed Services Committee and House Armed Services Committee leaders over the potential impact of the administration’s fiscal year 2013 budget on Tricare beneficiaries and community pharmacy.

  • NACDS expresses to FDA cautious optimism on the 'new paradigm' for third class of drugs

    ALEXANDRIA, Va. — The National Association of Chain Drug Stores submitted on Monday comments to the Food and Drug Administration regarding its position on the “new paradigm” for a third class of drugs.

    The comments were submitted to the FDA in conjunction with the agency’s hearing titled, “Using Innovative Technologies and Other Conditions of Safe Use to Expand Which Drug Products Can Be Considered Nonprescription.”

  • NCPA lobbies for bills that would help mitigate market dominance of new super-PBM ESI

    WASHINGTON — The battle for public opinion and legislative sway was in full swing Monday as executives from the National Community Pharmacists Association lobbied congressional leaders regarding several pieces of "pro-patient, pro-pharmacist legislation." To counter that effort, the Pharmaceutical Care Management Association issued some marketing firepower of its own.

  • New drug shortages cut in half as industry notifications increase

    SILVER SPRING, Md. — The number of new drug shortages has been halved as early notifications from manufacturers of potential shortages have increased sixfold, the commissioner of the Food and Drug Administration wrote Thursday.

  • Washington state health officials declare whooping cough epidemic

    OLYMPIA, Wash. — Washington state health officials have declared an emergency state action to slow the outbreak of whooping cough, also known as pertussis.

  • J&J seeks additional approval for anti-clotting drug

    RARITAN, N.J. — Drug maker Johnson & Johnson is seeking approval from the Food and Drug Administration for a drug to treat patients with deep vein thrombosis or pulmonary embolism, the company said.

    J&J division Janssen Research & Development announced the submission of a supplemental new drug application for Xarelto (rivaroxaban) to the FDA for the two conditions and for preventing recurrent venous thromboembolism.

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