MSN Lab gets CDSCO Panel Nod To Manufacture, Market Combi kit for Macitentan 10mg plus Tadalafil 20mg

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.

Pulmonary arterial hypertension (PAH) is one form of a broader condition known as pulmonary hypertension, which is high blood pressure in the lungs. In PAH, this increased pressure in the vessels is caused by an obstruction in the small arteries in the lung for a variety of reasons.

Tadalafil is a selective phosphodiesterase-5 inhibitor that is used in the treatment of erectile dysfunction (ED), pulmonary arterial hypertension (PAH), and benign prostatic hypertrophy.

Tadalafil is indicated for the treatment of pulmonary arterial hypertension (PAH) both alone and in combination with macitentan or other endothelin-1 antagonists

After detailed deliberation, the committee recommended the grant of permission for manufacturing and marketing of the fixed-dose combination (FDC) subject to the condition that the firm should conduct the Phase IV clinical trial.

Accordingly, the expert panel suggested that the firm should submit the Phase IV clinical trial protocol to CDSCO within 03 months of approval for review by the committee.

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