Skip to main content

Regulatory and Washington

  • CDC releases new TB treatment protocol

    ATLANTA — The Centers for Disease Control and Prevention on Thursday released new recommendations to treat latent tuberculosis infection.

    The new recommendations, published in CDC’s Morbidity and Mortality Weekly Report, provide guidance on how to administer a new 12-dose regimen for TB preventive therapy that will significantly shorten and simplify the course of treatment from about nine months to 12 weeks. The recommendations are based on the results of three clinical trials, as well as expert opinion.

  • FDA approves Antares Pharma's overactive bladder drug

    PARSIPPANY, N.J. — The Food and Drug Administration has approved a topical gel made by Antares Pharma for overactive bladder.

    Watson Pharmaceuticals announced Thursday the approval of oxybutynin gel in the 3% strength, which it will launch next year under a licensing agreement with Antares.

  • FDA panel votes in favor of Pfizer kidney cancer drug

    NEW YORK — A Food and Drug Administration panel of 13 advisers has voted in favor of a drug made by Pfizer for treating kidney cancer, the drug maker said Wednesday.

    Pfizer announced that the FDA's Oncologic Drugs Advisory Committee voted unanimously to state that axitinib's benefits outweighed its risks in patients with advanced renal cell carcinoma for whom first-line treatments had failed.

  • NACDS supports anticounterfeiting legislation

    ALEXANDRIA, Va. — New legislation proposed in the Senate would strengthen penalties against people who traffic in counterfeit medications.

    Introduced by Sen. Patrick Leahy, D-Vt., S. 1886, the Counterfeit Drug Penalty Enhancement Act of 2011, would harshen laws against producing, buying or selling counterfeit drugs. The bill has received support from the chain retail pharmacy lobby.

  • GPhA appoints new executive

    WASHINGTON — The Generic Pharmaceutical Association has appointed a new executive who will help guide the organization's newly created research and education institute.

    The organization announced Thursday the appointment of Ahaviah Glaser as VP policy and strategic alliances. Glaser previously was a member of AARP's government affairs team.

  • Medical community decries decision to maintain status quo of emergency contraceptive

    WASHINGTON — A group of medical associations on Wednesday denounced the government's decision to maintain the status quo with regard to the prescription status of the emergency contraceptive Plan B.

  • FDA seizes ephedrine ingredients

    SILVER SPRING, Md. — At the request of the Food and Drug Administration, U.S. marshals on Tuesday seized raw materials imported by Infinity Marketing Group containing ephedrine alkaloids, a large family of pharmacological compounds called sympathomimetics that have been banned by the FDA for use in dietary supplements since 2004.

    The seizure took place in Rancho Dominguez, Calif. Through this action, FDA removed more than $70,000 worth of dietary supplement ingredients from the market.

  • Report: Unions sue to stop Wash. liquor privatization

    NEW YORK — The state government of Washington is set to bow out of the liquor business on June 1 thanks to a ballot initiative that passed last month, but two labor unions are hoping to stop it, according to published reports.

X
This ad will auto-close in 10 seconds