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Regulatory and Washington

  • Perrigo gets OK for generic men’s Rogaine foam

    ALLEGAN, Mich. — The Food and Drug Administration has approved a generic version of Rogaine made by Perrigo, the drug maker said.

    Perrigo announced the FDA approval of over-the-counter minoxidil foam, a generic version of men’s Rogaine foam.

    Stiefel Research Australia, part of GlaxoSmithKline, sued Perrigo for patent infringement when the latter submitted its regulatory approval application. Under a settlement between the companies reached in February, Perrigo can launch its generic version of men’s Rogaine foam in March 2012.

  • NACDS chairman Loeffler emphasizes 'new normal' in inaugural remarks

    SCOTTSDALE, Ariz. — Proactivity. That was the common theme bridging presentations between H-E-B’s Bob Loeffler, incoming chairman of the National Association of Chain Drug Stores, and featured speaker Jeff Strong, Johnson & Johnson’s chief customer officer, during the closing business session at the 2011 NACDS Annual Meeting Tuesday morning.

  • Watson's generic Concerta enters market

    PARSIPPANY, N.J. — Watson Pharmaceuticals has launched an authorized generic version of a Johnson & Johnson drug for treating attention deficit hyperactivity disorder through a subsidiary, Watson said Monday.

    Watson announced the launch by Watson Labs of methylphenidate hydrochloride extended-release tablets under an agreement with J&J subsidiary Ortho-McNeil-Janssen.

  • Tradjenta approved as Type 2 diabetes treatment

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for Type 2 diabetes, the agency said Monday.

    The FDA announced the approval of Tradjenta (linagliptin), made by Indianapolis-based Eli Lilly and German drug maker Boehringer Ingelheim.

    “This approval provides another treatment option for the millions of Americans with Type 2 diabetes,” FDA Division of Metabolism and Endocrinology Products director Mary Parks said. “It is effective when used alone or when added to existing treatment regimens.”

  • FDA approves Abbott's AndroGel

    ABBOTT PARK, Ill. — The Food and Drug Administration has approved a treatment made by Abbott for low testosterone in men, the drug maker said Friday.

    Abbott announced the approval of AndroGel (testosterone gel) in the 1.62% strength, a clear, odorless topical gel for men with hypogonadism. The company already markets AndroGel in the 1% strength.

    The new gel contains 40.5 mg of testosterone in two pump presses, while AndroGel 1% contains 50 mg in four pump presses, but the company said the two were not interchangeable.

  • NACDS elects new 2011-2012 officers at Annual Meeting

    SCOTTSDALE, Ariz. — The National Association of Chain Drug Stores announced that Robert Loeffler will succeed Larry Merlo as the organization's new board of directors chairman, and also announced the appointment of several other elected officers, at its 2011 Annual Meeting.

    Loeffler, who serves as H-E-B's chief administrative officer, will replace Merlo, who is CVS Caremark president and CEO, as NACDS board chairman. Additionally, Walgreens president and CEO Greg Wasson was elected vice chairman, while Thrifty White president and CEO Robert Narveson was named treasurer.

  • APhA Foundation, NASPA honor Utah, Ohio pharmacists

    WASHINGTON — Pharmacists in Utah and Ohio have won the 2011 Bowl of Hygeia awards from the American Pharmacists Association Foundation and the National Alliance of State Pharmacy Associations, the two organizations announced.

    The APhA Foundation and NASPA announced that the Utah Pharmacists Association had given the award to Kathy Goodfellow, owner of Mountain View Pharmacy in Bountiful, Utah, and that the Ohio Pharmacists Association had given it to Mark Dominik of St. Mary’s, Ohio.

  • Zytiga OKed as prostate cancer treatment

    HORSHAM, Pa. — The Food and Drug Administration has approved a new treatment for prostate cancer made by Johnson & Johnson.

    Centocor Ortho Biotech, J&J’s biotech subsidiary, announced Thursday the approval of Zytiga (abiraterone acetate), a daily pill for use in combination with the corticosteroid prednisone for treating castration-resistant prostate cancer that has spread to other parts of the body in men who have received prior chemotherapy with Sanofi-Aventis’ Taxotere (docetaxel).

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