Glenmark gets CDSCO panel nod to manufacture ,market pulmonary FDC drug

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.