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Regulatory and Washington

  • NACDS endorses 'The Online Pharmacy Safety Act'

    ALEXANDRIA, Va. — The National Association of Chain Drug Stores on Tuesday expressed support for H.R. 4095, “The Online Pharmacy Safety Act,” which the organization said will help consumers protect themselves against the growing threat of illegitimate online drug sellers.

    NACDS sent a letter in support of the bill to its sponsors, Reps. Bill Cassidy, R-La., and Mike Ross, D-Ark. 

The bill requires the Department of Health and Human Services to create a public registry of law-abiding online pharmacy websites for consumer use.

  • FDA approves Biogen Idec's Avonex Pen, dose titration regimen

    WESTON, Mass. — The Food and Drug Administration has approved two separate dosing innovations for multiple sclerosis patients that are being treated with a Biogen Idec drug.

    Biogen Idec said the FDA approved Avonex pen, the first single-use, once-weekly intramuscular autoinjector approved for MS, and a dose titration regimen, which gradually escalates the dose of Avonex at treatment initiation. The drug maker said the new offerings are designed to improve the treatment experience.

  • FDA approves Hi-Tech Pharmacal epilepsy drug

    AMITYVILLE, N.Y. — The Food and Drug Administration has approved a drug for epilepsy made by Hi-Tech Pharmacal, the drug maker said Wednesday.

    Hi-Tech announced the approval of levetiracetam oral solution in the 100 mg-per-milliliter strength. The drug is a generic version of UCB Pharma's Keppra oral solution and is used to treat partial onset seizures in people ages 16 years and older.

    Various versions of the drug had sales of $62 million in 2011, according to IMS Health. Hi-Tech said it plans to launch the drug in May.

  • NCPA sends second letter addressing CMS' double-billing of certain enrollment fees

    WASHINGTON — The National Community Pharmacists Association last week sent a follow-up letter to the Centers for Medicare and Medicaid Services asking the agency to revisit a decision last month that effectively requires some pharmacies to pay duplicative fee-for-service Medicare enrollment/revalidation fees, according to the association.

  • Statins could increase blood sugar, cause cognitive problems, FDA says

    SILVER SPRING, Md. — Drugs widely used to treat cholesterol may cause increases in blood sugar and other symptoms, the Food and Drug Administration said Tuesday.

  • PTCB launches partnership program with employers

    WASHINGTON — An organization that certifies pharmacy technicians is starting a program designed to encourage more technicians to get certified.

    The Pharmacy Technician Certification Board announced Tuesday the launch of the Employer Partnership Program, which it said was for retail and health-system pharmacies that want to encourage technicians to participate in the PTCB certification program. North Carolina regional chain Kerr Drug already has joined the program, according to PTCB.

  • FDA exploring how to expand eligible Rx-to-OTC switches by utilizing pharmacy

    SILVER SPRING, Md. — The Food and Drug Administration on Tuesday announced it will hold a public hearing on March 22 and 23 to discuss how technology can expand which drug products can be switched from prescription to over-the-counter status.

  • FDA grants priority review to J&J heart drug

    RARITAN, N.J. — The Food and Drug Administration has given priority review to a regulatory application from Johnson & Johnson for a drug designed to reduce the risk of complications from internal blood clots.

    J&J's Janssen Research & Development division announced that the FDA had given the designation to Xarelto (rivaroxaban), an oral anticoagulant, to reduce the risk of certain types of heart attacks in patients with acute coronary syndrome, which 1.2 million Americans are diagnosed with every year.

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