US gov­ern­ment to SCO­TUS: Take up the Te­va-GSK 'skin­ny' gener­ic drug la­bel case

The US So­lic­i­tor Gen­er­al is call­ing on the Supreme Court to take up a fierce­ly de­bat­ed case that could have a chill­ing ef­fect on gener­ic drug com­pa­nies’ will­ing­ness to bring their copy­cats to mar­ket un­der so-called “skin­ny” la­bels, mean­ing the gener­ic can on­ly be ap­proved for some of the ref­er­ence prod­uct’s in­di­ca­tions.

The case in ques­tion re­lates to GSK’s win over Te­va in a long-run­ning bat­tle over the gener­ic gi­ant’s skin­ny la­bel for GSK’s be­ta-block­er Coreg (carvedilol). At the time in 2007, Te­va’s gener­ic la­bel first in­clud­ed two of the three Coreg in­di­ca­tions, but Te­va did not ini­tial­ly win ap­proval for the third in­di­ca­tion for con­ges­tive heart fail­ure.

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