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Regulatory and Washington

  • Hospira gets OK to market generic Taxotere

    LAKE FOREST, Ill. — Hospira has received approval from the Food and Drug Administration for a generic cancer treatment.

    Hospira will offer 20-mg, 80-mg and 160-mg vials of docetaxel at a 10-mg/mL concentration. Docetaxel is a generic version of Sanofi-Aventis's Taxotere.

    Hospira already markets docetaxel in Europe and Australia, the drug maker noted.

  • Under PEPFAR, Matrix Labs gets OK to sell zidovudine tablets

    PITTSBURGH — A subsidiary of Mylan has won approval to sell a generic drug for HIV and AIDS in developing countries under the President’s Emergency Plan for AIDS Relief.

    Mylan announced Thursday that Matrix Labs won Food and Drug Administration approval for zidovudine tablets in the 100-mg strength. The drug is a generic version of ViiV Healthcare’s Retrovir, an antiretroviral sold as a water-dispersible tablet. The drug is designed to treat HIV and AIDS in children and prevent transmission of the virus from pregnant mothers to their children.

  • N.Y. congresswoman introduces Preservation of Antibiotics for Medical Treatment Act

    WASHINGTON — A lawmaker from New York has introduced legislation designed to combat the rise of antibiotic-resistant bacteria.

    Keep Antibiotics Working, a Chicago-based organization, praised the Preservation of Antibiotics for Medical Treatment Act, introduced by Rep. Louise Slaughter, D-N.Y.

  • Benlysta approved as lupus treatment

    SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for lupus made by GlaxoSmithKline and Human Genome Sciences, the agency said Wednesday.

    The FDA approved Benlysta (belimumab), a treatment for systemic lupus erythematosus, the first new treatment for the autoimmune disease in 56 years.

  • FDA backs NCL's medication adherence campaign

    SILVER SPRING, Md. — The Food and Drug Administration is putting its weight behind a campaign by the National Consumers League to combat poor medication adherence.

  • NCPA's Jaeger responds to federal report identifying Medicare Part D overpayments

    ALEXANDRIA, Va. — A report by the Department of Health and Human Services' Office of Inspector General found that beneficiary premiums in the Medicare Part D prescription drug program are higher than than they should be, due to overpayments to plan sponsors, including pharmacy benefit managers.

  • NACDS, NCPA express support of 'swipe fee' reform

    ALEXANDRIA, Va. — The National Association of Chain Drug Stores and the National Community Pharmacists Association on Tuesday urged Congress to permit the Federal Reserve Board to expedite the implementation of an amendment to the financial-reform legislation from Sen. Dick Durbin, D-Ill., that would limit the fees charged to retail merchants on debit card transactions (known as “swipe fees”) to a level that is “reasonable and proportionate” to the costs incurred by the banks and credit card associations to process these transactions.

  • New bill looks to crack down on Rx theft, receives support from PSM

    WASHINGTON — Sens. Chuck Schumer, D-N.Y.; Jay Rockefeller, D-W.Va.; Amy Klobuchar, D-Minn.; and Sherrod Brown, D-Ohio, introduced new legislation that seeks to curb prescription drug theft through strengthened penalties and additional tools for law enforcement.

    If approved, the legislation would:

    • Increase possible sentences for robbing pharmacies of controlled substances;

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