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Dec 23, 2013
 |  BC Week In Review  |  Clinical News  |  Regulatory

Zohydro ER hydrocodone bitartrate regulatory update

In a letter to FDA Commissioner Margaret Hamburg, a group of 28 state attorneys general requested that the agency reconsider its approval of Zogenix's Zohydro ER hydrocodone bitartrate or set a "rigorous" timeline for the product to be reformulated to be abuse deterrent. Last month, the company partnered with Altus Formulation Inc. (Montreal, Quebec) to develop abuse-deterrent formulations of the product,...

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