Lupin receives FDA approval for generic Ortho Tri-cyclen Lo tablets

Lupin’s subsidiary, Lupin Pharmaceuticals 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. 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 US sales of approximately $ 421 million for the twelve months ending March 2012 (IMS Health sales data).

EP News Bureau – Mumbai

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