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FDA Acts Against Unapproved Narcotic Drugs

By H Bomber, Jun 15, 2009 | Updated: Jun 16, 2009 | |
  1. H Bomber
    FDA Acts Against Unapproved Narcotic Drugs

    SILVER SPRING, Md., March 31 -- The FDA has taken steps to pull 14 unapproved painkillers containing immediate-release morphine sulfate, oxycodone, and hydromorphone from the market.
    The agency has warned nine companies that make the unapproved products to stop manufacturing them within 60 days and to cease distribution within 90 days.

    Among the drugs affected by the enforcement action are two branded products containing morphine sulfate and oxycodone (Roxanol and Roxicodone, respectively) as well as generic versions of the three painkillers.

    All the affected products are tablets or oral solutions.

    Oxycodone capsules were not among the products targeted in the action, Deborah Autor, J.D., director of the compliance office in FDA's Center for Drug Evaluation and Research, emphasized at a press briefing today.

    Extended-release opioids were also unaffected by today's action.

    Patients who have been taking the unapproved medications are urged to seek prescriptions for equivalent or similar approved products.

    "We believe [the action] will not disrupt patient care," Autor said.

    She said some patients may have to switch to products not exactly identical to the unapproved drugs.

    Seven of the letters cited immediate-release 20 mg/mL morphine sulfate solutions. There is no approved version of morphine solution at that concentration, although 20 mg/5 mL is available.

    Autor said supplies of alternative products were sufficient to replace the unapproved products, even though immediate-release oxycodone appears on the FDA's most recent drug-shortage list, updated March 25.

    "There will be no shortage for consumers," she said.

    The companies told to pull their products are Mallinckrodt, Boehringer Ingelheim Roxane, Roxane Laboratories, Glenmark Generics, Lannett Company, Lehigh Valley Technologies, Physicians Total Care, Xanodyne Pharmaceuticals, and Cody Laboratories.

    Autor said the companies must submit responses to the warning letters within 15 days or face sanctions.

    At a press briefing announcing the action, Autor said the companies may seek approval for the products, but in the meantime they still must be pulled from the market.

    By John Gever, Senior Editor, MedPage Today
    Published: March 31, 2009

    Primary source: FDA
    Source reference:
    "Questions and Answers for Consumers about FDA's Action Involving Unapproved Narcotics Containing Morphine Sulfate, Hydromorphone, or Oxcodone" FDA 2009.


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