Bajaj Healthcare Scores Major CDSCO Green Light for Insomnia Buster Suvorexant Trials

Bajaj Healthcare Limited announced a pivotal regulatory milestone today, receiving formal approval from the Central Drugs Standard Control Organisation (CDSCO) to proceed with Clinical Trial and Bioequivalence Study for Suvorexant Tablets. This follows the Subject Expert Committee (SEC) on Neurology & Psychiatry's positive recommendation, confirming the company's readiness for advanced testing of the insomnia drug in strengths like 5mg, 10mg, 15mg, and 20mg. Suvorexant targets sleep-wake cycle modulation via the central nervous system, addressing a key need in adult insomnia management.

 

Key Developments

Sources: Marketscreener.com, Bajajhealth.com (official filings),

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