FDA nod for Lupin's oral contraceptive drug

Lupin Pharmaceuticals Inc., the subsidiary of the Mumbai-based Lupin Ltd has received final approval for its Pirmella Tablets (Norethindrone and Ethinyl Estradiol Tablets) from the United States Food and Drugs Administration (US FDA) to market a generic version of Janssen Pharmaceuticals, Inc.’s Ortho-Novum Tablets.

These tablets are indicated for the prevention of pregnancy.

The total sales for Ortho Novum Oral Contraceptive Tablets stood at $96.5 million (IMS MAT Dec 2012).

Lupin would commence shipping the product shortly, said a company statement.