Zohydro v. Massachusetts = Wyeth v. Levine? State Asserts Power To Seek Label Change

Arguing for its right to ban Zogenix Inc.’s opioid, Massachusetts contends that FDA clearance of a drug for marketing is a “gateway approval” that does not preempt states from imposing stricter requirements on a product.

Massachusetts is arguing in court that FDA clearance of a drug for marketing is a “gateway approval” that does not preempt states from imposing stricter requirements on a drug, in this case barring use of Zogenix Inc.’s opioid Zohydro ER (hydrocodone extended-release).

Last month Massachusetts Gov. Deval Patrick issued an emergency ban on the prescribing and dispensing of Zohydro ER until the...

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