MUMBAI, India and BALTIMORE, April 12, 2013 /PRNewswire/ --
Pharma major, Lupin Ltd., announced today that its subsidiary Lupin Pharmaceuticals Inc. (collectively Lupin) has received final approval for its Daysee™ Tablets (Levonorgestrel and Ethinyl Estradiol Tablets, USP, 0.15 mg/0.03 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg) from the United States Food and Drugs Administration (US FDA) to market a generic version of Teva Branded Pharm.'s Seasonique Tablets®. Lupin has already commenced shipping the product.
Lupin's Daysee™ Tablets is indicated for use by women to prevent pregnancy.
Lupin's Daysee™ Tablet (Levonorgestrel and Ethinyl estradiol tablets USP 0.15 mg/0.03 mg and Ethinyl estradiol tablets USP 0.01 mg) is available in Extended-Cycle Wallets each containing a 13-week supply of tablets: 84 light blue tablets, each containing 0.15 mg of Levonorgestrel and 0.03 mg of Ethinyl estradiol, and 7 mustard tablets, each containing 0.01 mg of Ethinyl estradiol. The light blue tablets are round, biconvex, film-coated tablets, debossed with "LU" on one side and "V21" on the other side. The mustard tablets are round, biconvex, film-coated tablets debossed with "LU" on one side and "V22" on the other side.
The total sales for Branded and generic sales for the product stood at USD 161 million (IMS MAT Dec 2012).
About Lupin Limited
Headquartered in Mumbai, Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded and generic formulations and APIs. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership positions in the Anti-TB and Cephalosporin segment.
Lupin is the 5th largest and fastest growing generics player in the US (5.1% market share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical company by sales. The Company is also the fastest growing top 10 generic pharmaceutical players in Japan and South Africa (IMS).