The Central Drug Standard Control Organization's (CDSCO) Subject Expert Committee (SEC) has given Synokem Pharmaceutical the go-ahead to conduct a Phase III clinical trial for the anti-allergic combination drug Montelukast (4 mg) plus Fexofenadine Hydrochloride (60 mg) Suspension.

This came after the firm presented the Phase-III CT study protocol of the anti-allergic combination drug Montelukast (4mg)plus Fexofenadine Hydrochloride (60mg) Suspension before the committee.

Montelukast plus Fexofenadine is a combination of two drugs, namely Montelukast (leukotriene receptor antagonist) and Fexofenadine (antihistamine).

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For the treatment of allergy symptoms in children, such as runny nose, sneezing, itching, swelling, congestion, and watery eyes, doctors frequently prescribe Montelukast plus Fexofenadine 4mg/60mg. It may also help in the treatment of asthma and skin allergies.

Montelukast belongs to the class of leukotriene receptor antagonists that work by blocking the action of chemicals called leukotrienes that are released from the lungs, causing inflammation (swelling) and increased mucus production in the airways.

This reduces inflammation, mucus production, and narrowing in the airways.

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Fexofenadine is a member of the class of antihistamines (anti-allergic medications) that suppresses allergic reactions by inhibiting the action of histamine.

It helps to provide relief from symptoms of allergy such as sneezing, running nose, watery eyes, itching, swelling, and congestion or stiffness.

At the SEC meeting for Pulmonary held on September 29, 2022, the expert panel reviewed the phase III clinical trial protocol of the anti-allergic combination drug Montelukast (4mg)plus Fexofenadine Hydrochloride (60mg) Suspension presented by the firm.

After detailed deliberation, the committee recommended the grant of permission to conduct the proposed Phase-III clinical trial (CT).

In addition, the committee asked the firm to submit the results of the study of the Phase III clinical trial for further review.

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