Lupin’s subsidiary gets US FDA approval for Pirmella 7/7/7 and Pirmella 1/35 tablets

27 Apr 2013 Evaluate

Lupin’s subsidiary - Lupin Pharmaceuticals Inc.has received final approval for its Pirmella 7/7/7 (Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/ 0.035mg, 0.75mg/ 0.035mg and 1mg/0.035mg) and Pirmella 1/35 tablets (Norethindrone and Ethinyl Estradiol Tablets USP1mg/0.035mg) from the United States Food and Drugs Administration (US FDA) to market a generic version of Janssen Pharmaceuticals, Inc’s Ortho-Novum 7/7/7 tablets and Ortho-Novum 1/35 tablets..

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 tablets and Ortho-Novum 1/35 oral contraception tablets stood at $96.50 million. 

Lupin is the 5th largest and fastest growing generics player in the US (5.1% market share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical company by sales. The company is also the fastest growing top 10 generic pharmaceutical players in Japan and South Africa (IMS).

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