Lupin announced that its subsidiary Lupin Pharmaceuticals Inc. 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 US Food and Drugs Administration to market a generic version of Teva’s branded drug Seasonique. Lupin has already commenced shipping the product.
Lupin’s daysee tablets is indicated for use by women to prevent pregnancy.
It 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.
As per IMS MAT Dec 2012 data the total sales for branded and generic sales for the product stood at $161 million.
EP News Bureau – Mumbai