Express Pharma

Lupin launches generic Ortho Tri-Cyclen tablets in the US

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It is indicated for use by females of reproductive potential to prevent pregnancy

Lupin has announced that its US subsidiary, Lupin Pharmaceuticals 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’ 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).

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).

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