Lupin’s arm launches Norgestimate and Ethinyl Estradiol Tablets USP

20 Jul 2016 Evaluate

Lupin’s US subsidiary, Lupin Pharmaceuticals Inc. has launched its Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg / 0.035 mg, 0.215 mg / 0.035 mg and 0.25 mg / 0.035 mg, having received an approval from the United States Food and Drug Administration (FDA) earlier to market a generic version of Janssen Pharmaceuticals, Inc.'s Ortho Tri-Cyclen Tablets (Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg / 0.035 mg, 0.215 mg / 0.035 mg and 0.25 mg / 0.035 mg).

Lupin's Norgestimate and Ethinyl Estradiol Tablets are the AB rated generic equivalent of Janssen Pharmaceuticals, Inc.'s Ortho Tri-Cyclen Tablets. It is indicated for use by females of reproductive potential to prevent pregnancy. It is also indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. It should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. Ortho Tri-Cyclen had US sales of $177.6 million (IMS MAT March 2016).

Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded & generic formulations, biotechnology products and APIs globally.

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