Drug maker Lupin today said it 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,Lupin said in a statement. 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,it added. 'LoSeasonique' is patented by Teva Women's Health Inc. "Lupin believes that it is one of the first applicants to file an abbreviated new drug application (ANDA) for LoSeasonique Tablets and will be entitled to 180 days of marketing exclusivity," it added. Commenting on the approval Lupin Group President Nilesh Gupta said: "We are very happy to receive this approval. This product approval demonstrates our commitment to deliver a quality Oral Contraceptive pipeline to consumers in the US,built around our development and vertically integrated manufacturing strengths. 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. Shares of Lupin today closed at Rs 474.10 on the BSE,down 1.79 per cent from its previous close.
