MSN Lab gets CDSCO Panel Nod To Manufacture, Market Combi kit for Macitentan 10mg plus Tadalafil 20mg
New Delhi: Granting approval for Phase III clinical trial and bioequivalence (BE) study wavier, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has given its nod to pharmaceutical major, MSN laboratories to manufacture and market Combi kit for Macitentan 10mg plus Tadalafil 20mg indicated for the treatment of Pulmonary arterial hypertension.
This nod is subject to the condition that the firm should conduct the Phase IV clinical trial.
This came after MSN laboratories presented its proposal before the committee along with justification for the Phase III clinical trial and BE study waiver for Macitentan 10mg plus Tadalafil 20mg combination.
Macitentan is an endothelin receptor antagonist used to manage pulmonary arterial hypertension to delay disease progression. Macitentan acts primarily by reducing vasoconstriction and cell proliferation due to endothelin overexpression.
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