April 16, 2014
Zogenix Prevails in Initial Challenge to Massachusetts Emergency Order Banning ZOHYDRO ER
By Kurt R. Karst –
When we first heard about the Complaint and Motion for Preliminary Injunction Zogenix, Inc. filed against Massachusetts Governor Deval Patrick, among others, alleging that the Commonwealth’s ban on FDA-approved ZOHYDRO ER (hydrocodone bitartrate) Extended-release Capsules is unconstitutional because the ban violates the Supremacy Clause of the U.S. Constitution (as well as the dormant Commerce Clause and the federal Contracts Clause), we thought Zogenix would have a pretty good shot at a quick win on preemption grounds. But we were concerned about the implications a win for the Commonwealth could have on FDA’s stamp of approval – would it undermine FDA and the drug approval process? (See our previous post here.)
continue to read here
When we first heard about the Complaint and Motion for Preliminary Injunction Zogenix, Inc. filed against Massachusetts Governor Deval Patrick, among others, alleging that the Commonwealth’s ban on FDA-approved ZOHYDRO ER (hydrocodone bitartrate) Extended-release Capsules is unconstitutional because the ban violates the Supremacy Clause of the U.S. Constitution (as well as the dormant Commerce Clause and the federal Contracts Clause), we thought Zogenix would have a pretty good shot at a quick win on preemption grounds. But we were concerned about the implications a win for the Commonwealth could have on FDA’s stamp of approval – would it undermine FDA and the drug approval process? (See our previous post here.)
continue to read here
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