Fed­er­al cir­cuit up­holds Te­va-Glax­o­SmithK­line de­ci­sion, land­ing an­oth­er blow to 'skin­ny' la­bels

Nor­mal­ly, new gener­ic drug com­pe­ti­tion can en­ter the mar­ket for one or some of the ap­proved in­di­ca­tions of its brand-name coun­ter­part’s la­bel. That new gener­ic drug’s la­bel, known as a “skin­ny” la­bel be­cause it doesn’t in­clude all of the ref­er­ence prod­uct’s in­di­ca­tions, hasn’t been a le­gal is­sue over the years for gener­ic de­vel­op­ers.

But that prece­dent is be­gin­ning to change with a re­cent rul­ing in a bat­tle be­tween Te­va and Glax­o­SmithK­line, over GSK’s be­ta-block­er Coreg (carvedilol), which Te­va launched a gener­ic of in 2007. At the time, Te­va’s carvedilol gener­ic la­bel in­clud­ed on­ly two of the three Coreg in­di­ca­tions: one to re­duce car­dio­vas­cu­lar mor­tal­i­ty in pa­tients suf­fer­ing from left ven­tric­u­lar dys­func­tion fol­low­ing a heart at­tack, and an­oth­er re­lat­ed to hy­per­ten­sion. Te­va did not win ini­tial ap­proval for the third in­di­ca­tion re­lat­ed to con­ges­tive heart fail­ure.

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