Lupin Pharmaceuticals has gained FDA approval for its Norgestimate and Ethinyl Estradiol tablets, 0.18mg/0.025mg, 0.215mg/0.025mg, and 0.25mg/0.025mg.
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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.
Lupin’s Norgestimate and Ethinyl Estradiol tablets are the AB-rated generic equivalent of Janssen Pharmaceuticals’ Ortho Tri-cyclen Lo tablets, 0.18mg/0.025mg, 0.215mg/0.025mg, and 0.25mg/0.025mg.
According to IMS Health sales data, Ortho Tri-cyclen Lo tablets had annual US sales of approximately $421m for the twelve months ending March 2012.
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