Lupin has received final approval for its Pirmella 7/7/7 (Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg and 1mg/0.035 mg) and Pirmella 1/35 Tablets (Norethindrone and Ethinyl Estradiol Tablets USP, 1 mg/0.035 mg) from the United States Food and Drugs Administration (US FDA) to market a generic version of Janssen Pharmaceutical’s Ortho-Novum 7/7/7 tablets and Ortho-Novum 1/35 tablets. Lupin would commence shipping the product shortly.
Lupin’s Pirmella 7/7/7 and Pirmella 1/35 Tablets is indicated for the prevention of pregnancy in women who elect to use the product as a method of contraception. The total sales for both Ortho Novum 7/7/7 and Ortho Novum 1/35 oral contraceptive tablets stood at $96.5 million.
EP News Bureau – Mumbai
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