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  • FDA Antiviral Drugs Advisory Committee recommends approval for J&J hepatitis C drug

    NEW YORK — A Food and Drug Administration expert panel has recommended approval for a drug made by Johnson & Johnson for treating hepatitis C, the company said.

    J&J subsidiary Janssen Research & Development said the 19-member FDA Antiviral Drugs Advisory Committee voted unanimously to recommend approval for TMC435 (simeprevir), a 150-mg drug meant for administration once per day with the generic antiviral ribavirin and a biotech drug known as an interferon, for treating genotype 1 chronic hepatitis C.

  • FDA approves first single-entity, extended-release hydrocodone drug

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new opioid painkiller made by Zogenix, the agency said Friday.

    The FDA announced the approval of Zohydro ER (hydrocodone) extended-release capsules for the management of pain severe enough to require daily, around-the-clock, long-term treatment. The agency said the drug was the first extended-release hydrocodone product not combined with another drug, such as acetaminophen, to be approved by the agency.

  • All American Pet Co. to sell NutraBars for dogs at Albertsons

    LOS ANGELES — Albertsons has placed an order for what is being called the "first true food bar" for dogs.

    All American Pet Co. said Friday it received an order from the grocer for NutraBars, which are designed to be high in protein and low in fat, and are made in the United States.

    The company said it also was expecting an order for Chewies Dog Treats, which are all-natural and made with peanuts, cheese and bacon. Albertsons, based in Boise, Idaho, operates 1,119 stores under 12 banners in 29 states.

     

  • Clinical trial results support experimental Gilead drug for hepatitis C as safe, effective, FDA records show

    NEW YORK — An experimental drug under development by Gilead Sciences for hepatitis C is safe and effective when combined with other treatments, according to a review posted on the Food and Drug Administration's website ahead of an expert panel meeting to take place Friday.

  • FDA approves subcutaneous Actemra for rheumatoid arthritis

    SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a new formulation of a drug made by Genentech for rheumatoid arthritis that can be injected into the skin.

    Genentech announced the approval of a subcutaneous formulation of Actemra (tocilizumab) in adults for adults with moderate RA who have not found sufficient relief by taking such disease-modifying antirheumatic drugs as methotrexate. Like the intravenous formulation of Actemra, the new version can be used alone or with drugs like methotrexate.

  • FDA designates Merck hepatitis C drug as breakthrough therapy

    WHITEHOUSE STATION, N.J. — The Food and Drug Administration has granted breakthrough therapy designation to an experimental drug made by Merck for hepatitis C, the drug maker said.

  • CFC inhalers to be phased out by end of year, FDA says

    SILVER SPRING, Md. — The Food and Drug Administration plans to complete its phase out of inhalers that contain ozone-depleting chlorofluorocarbons by the end of the year, the agency said Wednesday.

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