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Regulatory and Washington

  • Florida Senate committee passes biosimilar bill

    WASHINGTON — A committee of Florida's state Senate has passed a bill that could limit the use of biosimilars in the state.

    The Florida Senate Committee on Health Policy passed S.B. 732, sending it to the full state senate. The legislation would require pharmacists to inform doctors when a follow-on biologic was substituted for a brand-name biotech drug. The bill is similar to one signed into law last month by Virginia Gov. Bob McDonnell.

  • FDA grants tentative approval to Aurobindo HIV drug

    HYDERABAD, India — The Food and Drug Administration has given preliminary approval to a drug made by Aurobindo Pharma for treating HIV infection in developing countries, the drug maker said.

    Aurobindo announced that it had received tentative approval for efavirenz/emtricitabine/tenofovir disoproxil fumarate combination tablets in the 600-mg/200 mg/300-mg strength. The drug is a generic version of Gilead Sciences' Atripla.

  • URAC gives accreditation to PBM-owned specialty pharmacy

    LISLE, Ill. — Washington-based accrediting organization URAC has accredited pharmacy benefit manager Catamaran Corp.'s specialty pharmacy brand, Catamaran said.

    The PBM said BriovaRx had been awarded URAC's Specialty Pharmacy Accreditation. Catamaran said URAC offered the only third-party, voluntary accreditation program of this scope for the pharmacy benefit management and prescription services industry.

  • NCPA responds to CMS call letter

    ALEXANDRIA, Va. — The recent call letter released by the Centers for Medicare and Medicaid Services addresses issues that can have an adverse effect on the program's cost and quality of care, a trade group representing independent retail pharmacies said Wednesday.

    Commenting on the CMS' announcement, the National Community Pharmacists Association said it had prepared a detailed list for its members.

  • FDA approves new allergy drug for children

    MONMOUTH JUNCTION, N.J. — The Food and Drug Administration has approved a new drug for allergies in children made by Tris Pharma, the drug maker said Wednesday.

    Tris announced the approval of Karbinal ER (carbinoxamine maleate) extended-release oral suspension in the 4 mg-per-five milliliter strength. The company said the drug was the first sustained-release histamine receptor blocking agent for seasonal and perennial allergic rhinitis in children 2 and older.

  • FDA approves Mylan genital herpes ointment

    PITTSBURGH — The Food and Drug Administration has approved a new drug for genital herpes made by Mylan, the drug maker said Wednesday.

    Mylan announced the approval of acyclovir ointment in the 5% strength. The drug is a generic version of Valeant International's Zovirax, used to manage initial genital herpes and in limited, non-life-threatening mucocutaneous herpes simplex virus infections in patients with compromised immune systems.

  • CMS sees 'stable path' for Medicare Advantage in 2014

    WASHINGTON — Next year, for the first time since Medicare Part D's inception, the deductible for the defined standard plan will be lower than in previous years, as healthcare spending across the country has been growing, with Medicare spending per beneficiary at 0.4% in 2012.

  • Rx Response reporting system gets name change

    NEW ORLEANS — A coalition of drug and pharmacy organizations formed to address patients' medication needs during disasters is changing the name and Web address of its reporting system to make it easier to remember, the organization said Tuesday.

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