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Regulatory and Washington

  • 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.

  • 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.

  • Merck seeks FDA approval for Saflutan

    WHITEHOUSE STATION, N.J. — The Food and Drug Administration has accepted an approval application from Merck for a drug to treat eye diseases, Merck said Wednesday.

    Merck is seeking approval for Saflutan (tafluprost) ophthalmic solution, an investigational drug for relieving eye pressure in patients with glaucoma and ocular hypertension.

  • Tris seeks FDA OK for allergy treatment for kids

    MONMOUTH JUNCTION, N.J. — The Food and Drug Administration has accepted a regulatory approval application from Tris Pharma for a drug to treat allergies in children ages 2 years and older, Tris said Wednesday.

    Tris said that if approved, its carbinoxamine extended-release oral suspension would provide an alternative to currently available immediate-release formulations.

  • Third annual NACDS RxImpact Day in full swing

    ALEXANDRIA, Va. — Capitol Hill will turn into a sea of white lab coats Wednesday and Thursday as more than 350 pharmacy advocates from almost 40 states visit Washington for the third annual National Association of Chain Drug Stores RxImpact Day, NACDS said Wednesday.

    The event will include pharmacy and retail executives, division and store managers, pharmacists, pharmacy school deans and students advocating on behalf of pharmacy to members of Congress.

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