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Lupin gets USFDA nod for generic oral contraceptive tablets

31 Oct 2011 Evaluate

Drug maker Lupin has received final approval from the US health regulator to sell its generic version of 'LoSeasonique' tablets, an oral contraceptive drug, in the American market with 180 days of marketing exclusivity. The approval has been granted to Lupin Pharmaceuticals Inc, the US arm of the company. The nod by the US Food and Drug Administration(USFDA) is for Levonorgestrel and Ethinyl Estradiol tablets in strengths of 0.1 mg and 0.02 mg and for Ethinyl Estradiol tablets of 0.01 mg.

'LoSeasonique' is patented by Teva Women's Health Inc. The approval for generic version of LoSeasonique tablets is the third approval for the Mumbai-headquartered firm in the oral contraceptives portfolio. On September 20, the company had received USFDA approval to market generic norethindrone tablets in the strength of 0.35 mg. Earlier this month, the company launched a generic version of Femcon Fe, birth control chewable tablets, in the US market. 

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