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Lupin launches Ortho-Cyclen tablets in US

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Lupin Limited has launched its Norgestimate and Ethinyl Estradiol Tablets USP, 0.25 mg/0.035 mg having received approval from the United States Food and Drug Administration (FDA) earlier to market a generic version of Janssen Pharmaceuticals, Inc.’s Ortho-Cyclen 28 Tablets (Norgestimate/Ethinyl Estradiol).

Lupin’s Norgestimate and Ethinyl Estradiol Tablets USP, 0.25 mg/0.035 mg are the AB rated generic equivalent of Janssen Pharmaceuticals, Inc.’s Ortho-Cyclen 28 Tablets (Norgestimate/Ethinyl Estradiol). It is indicated for use by females of reproductive potential to prevent pregnancy.

Ortho-Cyclen 28 Tablets had US sales of USD 204 mn.

Earlier, the company also received final approval for its Paroxetin Extended Release Tablets USP, 12.5 mg, 25 mg and 37.5 mg from the United States Food and Drug Administration (FDA) to market a generic version of Apotex Technologies, Inc’s Paxil CR Tablets, 12.5 mg, 25 mg and 37.5 mg.

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