Lupin received final approval for its levonorgestrel and ethinyl estradiol tablets USP, 0.1 mg / 0.02 mg from the US FDA to market a generic version of Watson Laboratories’ Lutera 28 tablets, which had annual US sales of approximately $103.6 million. The company’s seventh OC product approval, Lupin’s levonorgestrel and ethinyl estradiol tablets are a combined oral contraceptive indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Lupin will be marketing its generic product shortly. The fifth largest generic player by prescription, Lupin is the most vertically integrated OC player for the US market and has a dedicated OC facility in Indore. Lupin’s current ANDA filings for OC’s stand at 32 – which is the largest pipeline for the US OC market.
EP News Bureau – Mumbai