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Regulatory and Washington

  • Legislation introduced to restore OTCs as eligible FSA expenses without a prescription

    WASHINGTON — U.S. Sens. Pat Roberts, R-Kan., and Mary Landrieu, D-La., on Tuesday introduced legislation that repeals a portion of Obamacare that prohibits people from using their medical savings account funds to buy over-the-counter medications. Under current law, plan participants may no longer use funds from these accounts to purchase OTC medications, unless they have a prescription for the medication.

  • Reports: Mich. bill would allow marijuana sales in pharmacies

    NEW YORK — State legislators in Michigan are considering a bill that would allow pharmacies to sell medical marijuana, according to published reports.

  • FDA approves generic injectable antibiotic

    SILVER SPRING, Md. – The Food and Drug Administration has approved a generic injectable antibiotic drug made by Emcure Pharmaceuticals, according to the agency.

    The FDA approved Emcure's vancomycin hydrochloride injection in the 5-g-per-vial strength.

    The drug is a generic version of Vancocin, made by ViroPharma.

     

  • FDA approves Mylan's generic version of Detrol LA

    SILVER SPRING, Md. — The Food and Drug Administration has approved a generic drug made by Mylan for treating overactive bladder, according to agency records.

    The FDA approved Mylan's tolterodine tartrate extended-release capsules in the 2-mg and 4-mg strengths.

    The drug is a generic version of Pfizer's Detrol LA. Detrol LA has annual sales of about $700 million, according to published reports.

     

  • Perrigo recalls APAP infant suspension liquid due to the possibility of missing dose markings on the dosing syringe

    ALLEGAN, Mich. —  Perrigo on Friday initiated a voluntary, nationwide product recall to the retail level of 18 batches of its acetaminophen infant suspension liquid, 160 mg/5 mL, sold in 2 oz. and 4 oz. bottles with syringes in a box because of the remote potential that a small number of packages might contain an oral dosing syringe without dose markings. 

  • FDA approves injectable morphine product from BD

    FRANKLIN LAKES, N.J. — The Food and Drug Administration has approved a new injectable painkiller made by Becton, Dickinson and Co., the medical products manufacturer said Monday.

    BD announced the FDA approval of morphine sulfate injection as part of its BD Simplist line of ready-to-administer pre-filled injectables. The drug was approved in the 2-mg-per-mL, 4-mg-per-mL, 5-mg-per-mL, 8-mg-per-mL and 10-mg-per-mL strengths.

  • FDA asks Ariad Pharmaceuticals to suspend sales, marketing of Iclusig amid side-effect concerns

    SILVER SPRING, Md. — The Food and Drug Administration has asked Ariad Pharmaceuticals to suspend marketing and sales of a chemotherapy drug for leukemia due to the risk of life-threatening side effects, the agency said.

  • UCB seeks approval for Vimpat as stand-alone therapy in adults

    ATLANTA — Drug maker UCB is seeking approval for one of its drugs as a stand-alone therapy for epilepsy.

    The company said Monday that the Food and Drug Administration had accepted its regulatory approval application for Vimpat (lacosamide) for adult epilepsy patients with partial-onset seizures. The drug is already approved as an add-on therapy for partial-onset seizures in patients aged 17 and older.

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