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Regulatory and Washington

  • OTC industry homogenizes concentration of APAP liquids for kids

    WASHINGTON — The Consumer Healthcare Products Association on Wednesday announced plans to convert liquid pediatric acetaminophen products to just one concentration.

    This voluntary change means the current children’s strength of liquid acetaminophen (160 mg/5 mL) will become the only liquid concentration available for all children younger than 12 years, and the current concentrated infant drops no longer will be sold.

  • FDA sets standards for liquid OTC dosage devices

    SILVER SPRING, Md. — The Food and Drug Administration on Wednesday released the Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products guidance, which outlines how easy-to-use dosage delivery devices and devices that minimize the risk of unintentional overdose can be provided for such over-the-counter medicines as liquid pain relievers, cold medicine, cough syrups and digestion aids.

  • FDA issues first new rules of Food Safety Modernization Act

    SILVER SPRING, Md. — The Food and Drug Administration has unveiled two regulations, part of the newly enacted Food Safety Modernization Act, that will take effect in July.

  • FDA warns consumers over fake products that claim to treat STDs

    SILVER SPRING, Md. — The Food and Drug Administration is cracking down on companies that it accuses of selling fake products for sexually transmitted diseases, the agency said.

    The FDA said at least 15 products — some sold as dietary supplements — that claim to treat, prevent or cure such STDs as herpes, Chlamydia, genital warts and HIV/AIDS, were being sold online and at some retail stores. Brands include MedaVir, which claims to treat herpes; Gene-Eden, which claims to treat a range of STDs, as well as flu and mononucleosis; and several others.

  • Quality Care Pharmacies joins NCPA

    ALEXANDRIA, Va. — The National Community Pharmacists Association's membership has expanded to include a buying and advertising cooperative that offers rebates and signage to independently owned pharmacies.

    Quality Care Pharmacies — a Springville, N.Y.-based company that boasts more than 450 member pharmacies in New York, New Jersey, Pennsylvania, Connecticut and Ohio — has joined NCPA, the association said.

  • Diabetes Advocacy Alliance to raise awareness of potential diabetes epidemic

    WASHINGTON — With the number of Americans with diabetes set to rise to 50 million by 2025, educating people is one of the most important steps for heading off the epidemic.

  • Sandoz gets OK for generic Yaz

    PRINCETON, N.J. — The Food and Drug Administration has approved a generic oral contraceptive made by Sandoz, the generics arm of Swiss drug maker Novartis said Wednesday.

    Sandoz announced the approval of Loryna (drospirenone 3 mg and ethinyl estradiol 0.02 mg) tablets, a generic version of Bayer HealthCare Pharmaceuticals’ Yaz.

  • Mylan's Q1 sales increase by 12%; judge dismisses case against FDA

    PITTSBURGH — Sales at generic drug maker Mylan increased by 12% during first quarter 2011, compared with first quarter 2010, the company said Tuesday.

    Sales for the three months ended March 31 were $1.45 billion, compared with $1.29 billion during the same period a year ago. Profits, meanwhile, were $104.2 million, compared with $61.1 million in first quarter 2010.

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