FDA approves Lupin’s Norgestimate and Ethinyl Estradiol Tablets

Pharma major, Lupin Ltd., announced today that its subsidiary, Lupin Pharmaceuticals Inc. (collectively, Lupin) has received approval for its Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg from the United States Food and Drugs Administration (FDA).

Lupin's Norgestimate and Ethinyl Estradiol Tablets are the AB-rated generic equivalent of Ortho Tri-cyclen Lo^® Tablets,0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, of Janssen Pharmaceuticals, Inc.. Norgestimate and Ethinyl Estradiol Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

Ortho Tri-cyclen Lo^® Tablets had annual U.S sales of approximately US$ 421 million for the twelve months ending March 2012 (IMS Health sales data).