To launch NDA product ZYPITAMAG (pitavastatin magnesium) in USZydus Cadila announced that it has entered into a definitive agreement with Medicure International Inc., a subsidiary of Medicure Inc. (Medicure) to commercialize its 505(b)(2) New Drug Application (NDA) product, pitavastatin magnesium (ZYPITAMAGTM) in the United States. The launch of ZYPITAMAG, which is used to manage cholesterol levels, marks the first branded product launch for Zydus in the U.S.
Medicure is a U.S. pharmaceutical company and has a proven track-record of successful commercialization of products in the therapeutic segments of cardiovascular and metabolic diseases. As a part of this agreement, Zydus will hold the NDA and Medicure will be responsible for the sales and marketing of ZYPITAMAG.
Approved in strengths of 1 mg, 2 mg and 4 mg, ZYPITAMAG is an HMG-CoA reductase inhibitor indicated for Patients with primary hyperlipidemia or mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase highdensity lipoprotein cholesterol (HDL-C).
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