Healthcare company Zydus Cadila said on Wednesday that it plans to commercialise its 505(b)(2) New Drug Application (NDA) of pitavastatin magnesium (ZYPITAMAGTM) in the US through a definite agreement with Medicure International Inc, a subsidiary of Medicure Inc. (Medicure).
ZYPITAMAG, which is approved in strengths of 1 mg, 2 mg and 4 mg, 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) as well as to increase high-density lipoprotein cholesterol (HDL-C), according to the company.
In conjunction, ZYPITAMAG's launch in the US will mark Zydus' first branded product launch and Medicure's second cardiovascular drug.
Pursuant to the agreement, Zydus will hold the NDA to the cholesterol product ZYPITAMAG and Medicure will be responsible for its sales and marketing.
Medicure is a US pharmaceutical company and has a proven track-record of successful commercialisation of products in the therapeutic segments of cardiovascular and metabolic diseases.
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