Lupin Ltd on Tuesday said that its wholly owned US subsidiary, Lupin Pharmaceuticals Inc., has received the final approval for its ‘levonorgestrel and ethinyl estradiol’ tablets from the United States Food and Drug Administration to market a generic version of Watson Laboratories’ ‘Lutera’ tablets.
Lupin’s levonorgestrel and ethinyl estradiol tablets, having a strength of 0.1 mg and 0.02 mg, are combined oral contraceptives indicated for the prevention of pregnancy in women who choose to use oral contraceptives as a method of avoiding pregnancy.
“Lupin will be marketing its generic product shortly,” the company said in a filing to the BSE.
Lutera tablets have annual sales of about $104 million.