FDA approves Lupin’s Norgestimate and Ethinyl Estradiol Tablets

Jul 4 2012

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).