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Regulatory and Washington

  • Reports: Canada to allow generic OxyContin approval over provincial, tribal objections

    NEW YORK — Canada's federal government has allowed the approval process for a generic opioid painkiller to go forward despite objections from provincial and other authorities, according to published reports.

    The Associated Press reported that Canadian health minister Leona Aglukkaq turned down requests from provincial and aboriginal tribal authorities to delay approval of a generic version of Purdue Pharma's OxyContin (oxycodone). OxyContin will lose its patent protection in Canada on Sunday.

  • Kentucky initiates awareness campaign around 'smurfing' of PSE products

    LEXINGTON, Ky. — Gov. Steve Beshear on Monday announced the launch of a privately funded, statewide campaign aimed at increasing public awareness about "smurfing," the illegal process of buying products containing pseudoephedrine on behalf of methamphetamine criminals. The goal of the Anti-Smurfing Campaign is to inform potential smurfers and the general public — through signage displayed at pharmacy sales counters — that smurfing is a serious criminal offense that can result in criminal charges and possibly time in jail. 

  • Report: Teen smoking falls significantly across 41 states

    ROCKVILLE, Md. — Current cigarette smoking among 12- to 17-year-olds fell significantly from 2002 to 2010 in 41 states, according to a report by the Substance Abuse and Mental Health Services Administration issued last week. The report also found that during the same period, adolescent perception of risk from cigarette smoking has remained unchanged in most states.

  • FDA approves GSK drug for hepatitis C patients with low platelet counts

    LONDON — The Food and Drug Administration has approved a drug for a condition that can complicate treatment for hepatitis C.

    GlaxoSmithKline said Monday that the FDA had approved Promacta (eltrombopag) for treating low blood-platelet counts, also known as thrombocytopenia, to allow patients with hepatitis C to undergo and maintain interferon-based therapy. The drug already had FDA approval to treat chronic immune thrombocytopenia. 

  • FTC clears Valeant-Medicis deal

    MONTREAL — The Federal Trade Commission has approved a deal by Valeant Pharmaceuticals International to buy a Scottsdale, Ariz.-based drug maker.

    Valeant said the FRC had finished reviewing its planned acquisition of Medicis Pharmaceutical and allowed the waiting period required under merger and acquisition laws to terminate early.

    Valeant said the deal is still subject to conditions like the approval of Medicis' stockholders, who will have a special meeting on Dec. 7. Medicis makes drugs for asthma, fungal infections and skin conditions like acne and eczema.

  • FDA panel advises against Merck's Oxytrol patch Rx-to-OTC switch application

    SILVER SPRING, Md. — The Food and Drug Administration's Nonprescription Drugs Advisory Committee on Friday voted against Merck's application to switch its Oxytrol patch from prescription-only to over the counter, citing concerns over use of therapy for an overactive bladder in women without a doctor's intervention. 

    The committee voted five in favor and six opposed, also citing concerns that men might inappropriately choose to use the product as well. 

  • Frito-Lay's new caffeinated line of Cracker Jacks elicits criticism from CSPI

    PepsiCo's Frito-Lay has stirred up controversy with its plan to launch an extended line of Cracker Jacks snacks, called Cracker Jack'd, which includes a caffeinated snack called Power Bites.

  • FDA wants more oversight of compounding pharmacies

    NEW YORK — Food and Drug Administration commissioner Margaret Hamburg is asking Congress to give the agency more power to regulate compounding pharmacies amid a nationwide meningitis outbreak linked to a Massachusetts-based compounding pharmacy that has claimed dozens of lives nationwide.

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