"We have received final approval for norgestimate and ethinyl estradiol tablets USP, 0.25 mg/0.035 mg, from the United States Food and Drug Administration (FDA) to market a generic version of Janssen Pharmaceuticals Ortho-Cyclen 28 tablets," a company statement said today.
The approved product will be manufactured at Lupin's Pithampur facility. It is indicated for use by females of reproductive potential to prevent pregnancy. Ortho-Cyclen tablets had US sales of USD 178.2 million.
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