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FDA Approves New Hydrocodone Product Despite Advisers’ Objections

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The FDA recently approved the first single-entity hydrocodone drug, Zohydro ER, citing the need for a stronger, extended-release painkiller for those in chronic pain. Critics of this decision cite the potential for increased prescription drug abuse; hydrocodone is the most prescribed drug in the nation and consistently one of the most abused according to the Drug Enforcement Agency. Before Zohydro ER, hydrocodone could only be found mixed with other analgesics in medications such as Vicodin. The FDA’s decision came as a surprise since its panel of outside advisers voted 11-2, with one abstention, against the approval of Zohydro last year. Also, the day before the approval, the FDA supported new regulations to prevent prescription drug abuse, including changing hydrocodone from a Schedule III to Schedule II drug (see previous post). Zohydro ER will be regulated as a Schedule II drug, and the FDA has required further study to assess the risk for abuse, but critics are still wary of the consequences of a pure, stronger hydrocodone drug.

FDA Announcement


One thought on “FDA Approves New Hydrocodone Product Despite Advisers’ Objections

  1. Pingback: Why Did The FDA Approve Zohydro ER? | AcuPartD

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