Pharma major, Lupin Ltd., announced that its subsidiary, Lupin Pharmaceuticals Inc. (LPI) has received final approval for its Levonorgestrel and Ethinyl Estradiol Tablets 0.1 mg /0.02 mg and Ethinyl Estradiol Tablets 0.01 mg from the U.S. Food and Drug Administration (FDA) for the company's Abbreviated New Drug Application (ANDA) to market a generic version of Teva Women's Health, Inc's. LoSeasonique® Tablets.
Lupin believes that it is one of the first applicants to file an ANDA for LoSeasonique® Tablets and will be entitled to 180 days of marketing exclusivity.
Commenting on the launch, Nilesh Gupta, Group President of Lupin 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 U.S., built around our development and vertically integrated manufacturing strengths. Consumers can be assured they are receiving quality products that they have been accustomed to, at a more affordable price".