Lupin Ltd. Aug. 1 announced that its U.S. subsidiary, Lupin Pharmaceuticals Inc., has received final approval from the Food and Drug Administration for its generic version of Gilead Sciences Inc.'s Ranexa (ranolazine) 500 mg and 1000 mg extended-release tablets.
Ranexa is indicated for treating chronic angina.
Lupin said it believes it is the first applicant to file an abbreviated new drug application for this product in the 500 mg and 1000 mg strengths, and it will be entitled to 180 days of marketing exclusivity.
Ranexa 500 mg and 1000 mg tablets had U.S sales of approximately $443.4 million for the ...
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