Drug firm Lupin on Tuesday said it has received final approval from the US health regulator to sell its generic oral contraceptive Levonorgestrel and Ethinyl Estradiol tablets in the American market.
Lupin Pharmaceuticals Inc, the company’s U.S.-based subsidiary, has received approval from the US Food and Drugs Administration (USFDA) to market its generic Levonorgestrel and Ethinyl Estradiol tablets USP, 0.1 mg / 0.02 mg, Lupin said in a statement.
The tablets are generic version of Watson Laboratories Inc’s Lutera 28 tablets, it added.
“Lutera tablets had annual sales of approximately USD 103.6 million as per IMS MAT Sept 2012 sales,” the Mumbai-headquartered company said.
The company will market its generic product shortly, it added.
Shares of Lupin were trading at Rs 584.35 on the BSE, down 1.57 per cent from its previous close.