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Regulatory and Washington

  • Water Quality and Health Council raising awareness of swimmer's ear with free pool test kits

    ATLANTA — Swimmer’s ear accounts for as many as 2.4 million doctor visits and nearly $500 million in healthcare costs annually, a Centers for Disease Control and Prevention report published Thursday in its "Morbidity and Mortality Weekly Report" found.

  • Edurant OKed as HIV treatment by FDA

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new antiretroviral treatment for HIV made by Johnson & Johnson, the agency said Friday.

    The FDA approved J&J subsidiary Tibotec Therapeutics’ Edurant (rilpivirine) as a treatment for use in combination with other HIV drugs in adults who have not been treated before.

  • Sandoz looks to market generic Vyvanse

    DUBLIN — Sandoz is looking to market a generic version of a Shire drug for treating attention deficit hyperactivity disorder.

  • FDA committee recommends approval of Abbott's Trilipix, statin combination

    ABBOTT PARK, Ill. — A Food and Drug Administration advisory committee has voted to recommend that the FDA retain approval of an Abbott drug for high cholesterol in combination with a statin.

    The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee met Thursday to discuss whether to recommend continued FDA approval of Trilipix (fenofibric acid) in combination with simvastatin in patients with mixed dyslipidemia and a high risk of heart disease. The FDA is not bound by advisory committee votes, but usually follows them.

  • Avandia to be available only by mail order in November, FDA asserts

    SILVER SPRING, Md. — A controversial GlaxoSmithKline drug for treating Type 2 diabetes no longer will be available through retail pharmacies as of Nov. 18, the Food and Drug Administration announced Wednesday.

  • NRF launches advocacy campaign to preserve swipe-fee reform

    WASHINGTON — The National Retail Federation on Wednesday launched a 60-day lobbying, grassroots and media campaign aimed at ensuring that a new federal law — which is designed to save retailers and their customers more than $1 billion a month by lowering the “swipe fees" banks charge to process debit card transactions — takes effect in late July as scheduled.

  • Reports: Unabomber alleged suspect in 1982 Tylenol poisonings

    CHICAGO — Theodore Kaczynski, also known as the Unabomber, allegedly is a suspect in the 1982 Tylenol poisonings in the Chicago area that killed seven people, according to published reports.

    The Tylenol poisonings, in which someone placed potassium cyanide in with the pain relievers on store shelves, prompted the introduction of tamper-proof packaging for many over-the-counter medicines.

  • CHPA praises FDA committees' decision to mandate weight-based dosing of APAP for children

    SILVER SPRING, Md. — Two Food and Drug Administration advisory committees on Wednesday unanimously voted in favor of mandating weight-based dosing for children between the ages of 2 and 12 years who are being administered acetaminophen.

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