Lupin’s subsidiary receives USFDA approval for Generic Ortho Tri-cyclen Lo tablets

03 Jul 2012 Evaluate

Lupin’s subsidiary - Lupin Pharmaceuticals Inc. (collectively Lupin) has received an 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 (USFDA).

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 Japanese 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 sales of approximately $421 million for the twelve months ending March 2012, as per IMS Health sales data.

Lupin has a vibrant presence in the Indian pharmaceuticals market and has over the past several years made major strides in expanding its therapy portfolio. The company has a robust promotion and distribution setup along with a strong presence in various therapeutic areas, including the fast growing diabetes market.

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