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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