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.
LivaNova announces commercial launch of Essenz Perfusion System in China
Viatris' generic iron sucrose injection gains US FDA approval
CorMedix to acquire Melinta Therapeutics in USD300m deal to expand infectious disease portfolio
US FDA approves Innovent's IND application for IBI3032 oral GLP-1R agonist
GEN and Sulfateq report positive Phase 1 data for SUL-238 in Alzheimer's
Philips launches ECG AI Marketplace to streamline cardiac diagnostics
AstraZeneca's Baxdrostat meets all endpoints in pivotal Phase III hypertension trial
Accord Healthcare introduces Dehydrated Alcohol Injection for cardiovascular indications
Innovent presents mazdutide Phase 3 clinical study results at ADA 85th Scientific Sessions
Breckenridge Pharmaceutical's generic for Ablysinol granted final FDA approval
Cumberland Pharmaceuticals reports ifetroban Phase 2 DMD heart disease trial results
EDX Medical and Spire Healthcare sign strategic diagnostic partnership agreement