FDA Approves More Powerful, Pure Hydrocodone Drug

The FDA announcement comes just a day after the agency said it would recommend stronger controls on combination drugs containing hydrocodone

Friday, Oct 25, 2013  |  Updated 11:42 AM PDT
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FDA Approves More Powerful, Pure Hydrocodone Drug

AP

In this Aug. 5, 2010, file photo, a pharmacy tech poses for a picture with hydrocodone bitartrate and acetaminophen tablets, the generic version of Vicodin, at Oklahoma Hospital Discount Pharmacy in Edmond, Okla.

The Food and Drug Administration has approved a stronger, single-ingredient version of the painkiller hydrocodone, the widely-abused prescription medicine for chronic pain.

The agency said it approved the pill Zohydro for patients with pain that requires, daily, around-the-clock treatment that cannot be addressed with other drugs.

The approval comes as a surprise since the agency's own panel of outside advisers gave an overwhelmingly negative review of the product last year. The FDA's panel of pain specialists voted 11-2 against approving the drug last December, questioning the need for a new form of one of most widely-abused prescription painkillers in U.S.

The FDA announcement also comes just a day after the agency said it would recommend stronger controls on combination drugs containing hydrocodone, such as Vicodin.

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