Glenmark gets CDSCO panel nod to manufacture ,market pulmonary FDC drug
New Delhi: The drug major Glenmark has got the go ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to manufacture and market a fixed dose combination pulmonary drug, which each capsule contains Indacaterol (as acetate) equivalent to Indacaterol 150 mcg, Glycopyrrolate IP equivalent to glycopyrronium 50 mcg, and Mometasone Furoate IP 160 mcg of dry powder for inhalation.
However, this approval is subject to the condition that the firm conduct the Phase IV clinical trial (CT).
This came after the firm presented the in-vitro comparison data of the FDC pulmonary drug before the committee.
In addition, the firm informed the committee that the product was already approved by CDSCO on November 7, 2022, with a condition to conduct Phase IV CT.
Indacaterol is an inhaled long-acting beta-2 adrenergic agonist used to relax bronchial smooth muscle and improve symptoms and airflow obstruction caused by Chronic Obstructive Pulmonary Disease (COPD) and moderate to severe asthma.
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