Exemed Pharma Gets CDSCO Panel Nod To Study FDC of Montelukast, Bilastine

Montelukast helps stop your airways from narrowing (caused by inflammation). This makes breathing easier and prevents asthma attacks. Most people take montelukast once a day in the evening. If you take it for asthma, it's important to take it even when you have no symptoms.

Bilastine is an antihistamine that is used to relieve the symptoms of allergic rhinoconjunctivitis (sneezing, itchy nose, nasal secretion, nasal congestion, and red, streaming eyes) and other forms of allergic rhinitis. It can also be used to treat itchy skin rashes (wheals or urticaria).

Bilastine is a new oral highly selective H1-receptor antagonist developed for the symptomatic treatment of allergic rhino-conjunctivitis and urticaria. It is an antiallergic agent whose main mechanism of action is the inhibition of immune system reactions mediated by the interaction of histamine on its H1- receptor.

At the recent SEC meeting for Pulmonary held on 5th July 2023, the expert panel reviewed the proposal presented by Exemed Pharmaceuticals along with BE study protocol and phase III clinical trial study protocol of the FDC pulmonary drug Montelukast Sodium plus Bilastine tablets

After detailed deliberation, the committee recommended the grant of permission to conduct the BE study and phase III clinical trial.

In accordance with the above, the expert panel stated that the firm should present the results of BE study for review by the committee before the initiation of the Phase III clinical trial.

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