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U.S. FDA chief defend approval of Zogenix's Zohydro 'unique' pain drug

Source: Reuters - Thu, 13 Mar 2014 14:14 GMT
Author: Reuters
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WASHINGTON, March 13 (Reuters) - U.S. Food and Drug Administration Commissioner Margaret Hamburg on Thursday defended the agency's approval of Zogenix Inc's Zohydro, saying the powerful prescription opioid offered a "unique" option to help treat pain.

Hamburg, responding to a query from a U.S. lawmaker, said that currently approved hydrocodone drugs also contain acetaminophen, which can be toxic to the liver at higher doses. Zohydro does not contain the added pain ingredient.

"We recognize that this is a powerful drug, but we also believe that if appropriately used, it serves an important and unique niche with respect to pain medication and it meets the standards for safety and efficacy," Hamburg said at a hearing of the Senate's Health, Education, Labor and Pensions Committee.

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