Lupin Ltd. Jan. 22 announced that its subsidiary, Lupin Pharmaceuticals Inc., has received final approval from the Food and Drug Administration for its generic version of Watson Laboratories Inc.'s Lutera 28 tablets (levonorgestrel and ethinyl estradiol 0.1 mg/0.02 mg tablets).
Lutera is a combined oral contraceptive indicated for preventing pregnancy. The Mumbai-based company said it will be marketing its generic product shortly.
Lutera had U.S. sales of approximately $103.6 million for the 12 months ended in September 2012, according to IMS Health.
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