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  • MSN Lab gets CDSCO...

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

Dr. Divya ColinWritten by Dr. Divya Colin Published On 2023-09-09T18:00:06+05:30  |  Updated On 9 Oct 2023 12:36 PM IST
CDSCO Panel nod to MSN Labs Tolvaptan Tablets
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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.

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.

Also Read:DCGI flags popular antacid Digene Gel, Abbott initiates recall

msn labscdscoMacitentantadalafilpulmonary arterial hypertensionMSN Laboratories
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

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