Akum Pharma Gets CDSCO Panel Nod to Study Cetirizine Ophthalmic Solution
New Delhi: The drug major Akum Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase III clinical trial of Cetirizine Ophthalmic Solution 0.24% w/v.
This came after Akum Pharmaceuticals presented a revised Phase III clinical trial protocol by including a reference arm and justification for sample size before the committee.
Cetirizine, a metabolite of hydroxyzine, is an antihistamine drug. Its main effects are achieved through selective inhibition of peripheral H1 receptors. Cetirizine is a relatively safe and effective medication for treating allergic rhinitis, urticaria, and allergic conjunctivitis. As cetirizine is also available over the counter, prescribers should educate patients on possible side effects, such as drowsiness, fatigue, and dry mouth, while dispensing medicine.
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