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.
Indacaterol works by stimulating adrenergic beta-2 receptors in the smooth muscle of the airways. This causes relaxation of the muscle, thereby increasing the diameter of the airways, which become constricted in asthma and COPD.
Glycopyrronium is an anticholinergic agent used to treat hyperhidrosis, severe drooling, and COPD. These medicines help to prevent the formation of secretions that can cause problems in your respiratory tract.
Mometasone furoate is a corticosteroid used to treat asthma, allergic rhinitis, nasal congestion, nasal polyps, dermatitis, and pruritus. Mometasone works as a corticosteroid hormone receptor agonist.
At the recent SEC meeting for pulmonary held on March 21, 2023, the expert panel reviewed the invitro comparison data of the FDC capsule containing Indacaterol (as acetate), equivalent to Indacaterol 150 mcg, plus Glycopyrrolate IP, equivalent to glycopyrronium 50 mcg, plus Mometasone Furoate IP 160 mcg of dry powder for inhalation.
After detailed deliberation, the committee considered in-vitro comparison data and recommended the grant of permission to manufacture and market the FDC with the condition to conduct the Phase IV CT.
Accordingly, the expert panel directed the firm that the Phase IV CT study protocol should be submitted to CDSCO within three months from the date of approval for review by the committee.
