Lupin receives USFDA approval for oral contraceptive generic

Lupin has recieved the approval for the generic version of Ortho Novum 7/7/7 and Ortho Novum 1/35 oral contraceptive tablets


Lupin Pharmaceuticals, a subsidiary of Lupin recently announced that it has received the 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 (USFDA) to market a generic version of Janssen Pharmaceuticals, 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 USD 96.5 million according to IMS MAT Dec 2012.

For the financial year ended March 2012, Lupin's Consolidated Total Income and Profit after Tax were Rs. 70,972 million (USD 1.49 billion) and Rs.8,676 million (USD 182 million) respectively.

Lupin Pharmaceuticals is the wholly owned U.S. subsidiary of Lupin Limited headquartered in Baltimore, Maryland.

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