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Specialty Pharmacy

  • FDA panel recommends approval of Remicade for UC in children

    HORSHAM, Pa. — A panel of experts at the Food and Drug Administration has recommended that the agency approve a drug made by Johnson & Johnson as a treatment for ulcerative colitis in children.

  • FDA OKs REMS for Fentora, Actiq

    FRAZER, Pa. — The Food and Drug Administration has approved a risk evaluation and mitigation strategy for two painkillers made by Cephalon, the drug maker said Thursday.

    The FDA approved a REMS for Fentora (fentanyl) buccal tablets and Actiq (oral transmucosal fentanyl citrate). Both drugs are used for managing breakthrough pain in cancer patients who have become tolerant of opioid drugs.

  • Purdue launches RxSafetyMatters.org

    STAMFORD, Conn. — Purdue Pharma has launched a new website designed to combat abuse of prescription drugs, the company said Wednesday.

    The website, RxSafetyMatters.org, is designed to help healthcare professionals, police and community organizations combat prescription drug diversion and abuse. Purdue is the developer of OxyContin (oxycodone), an extended-release painkiller that is frequently a target of drug abusers.

  • Investigational antidepressant garners positive results in late-stage clinical trial

    NEW YORK — Patients taking an investigative antidepressant undergoing late-stage clinical development showed “significant” improvement, according to study results released Monday.

    Forest Labs and Pierre Fabre Medicament announced results of a phase-3 trial of levomilnacipran in adults with major depressive disorder. Results showed a statistically significant improvement in patients treated with the drug, compared with those taking placebo.

  • Graceway receives regulatory approval for Zyclara

    BRISTOL, Tenn. — The Food and Drug Administration has approved a drug made by Graceway Pharmaceuticals for actinic keratoses, Graceway said.

    The agency approved Zyclara (imiquimod) cream in the 2.5% strength for AK, a precancerous lesion that affects about 10 million Americans and can develop into skin cancer later on.

  • QRxPharma seeks FDA approval for MoxDuo IR

    SYDNEY — Australian drug maker QRxPharma is seeking approval for a drug that combines two painkillers in one pill, the company said Monday.

    QRxPharma announced that it had filed a regulatory approval application with the Food and Drug Administration for MoxDuo IR (morphine and oxycodone). The drug is designed to release both drugs into the body immediately.

  • Upsher-Smith commences late-stage trial for epilepsy treatment

    MAPLE GROVE, Minn. — Upsher-Smith Labs has started a late-stage clinical trial of a drug for treating patients with a rare and severe form of epilepsy, the drug maker said Monday.

  • High adherence rates reported among patients in Walgreens' HCV therapy management program

    DEERFIELD, Ill. — Walgreens is recognizing medication adherence rates as high as 96% through its hepatitis C therapy management programs across its specialty pharmacy, the pharmacy operator announced Monday.

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