Third time’s the charm as Heron wins FDA nod for non-opi­oid anes­thet­ic Zyn­relef

With an aim to re­duce the use of opi­oids in the post-op set­ting, Heron Ther­a­peu­tics on Thurs­day an­nounced that it fi­nal­ly won FDA ap­proval — af­ter two pri­or CRLs — for its long-last­ing lo­cal anes­thet­ic, which is a com­bi­na­tion of bupi­va­caine and the NSAID meloxi­cam.

Heron will price the drug, known com­mer­cial­ly as Zyn­relef, some­where be­tween 22% and 28% less than its di­rect com­peti­tor, Paci­ra Bio­sciences’ Ex­par­el (bupi­va­caine li­po­some in­jectable sus­pen­sion), Heron CEO Bar­ry Quart told End­points News in an in­ter­view.

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