Sun Pharma gets CDSCO Panel Nod To Manufacture and market antianxiety drug Etifoxine HCl Capsule
New Delhi: Pharmaceutical major, Sun Pharma has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market anxiolytic agent Etifoxine HCl Capsule 50 mg for generalized anxiety disorder with somatic symptoms.
Furthermore, the expert panel recommended that the firm carry out a post-marketing surveillance (PMS) study with the primary aim of assessing the drug dependency of Indian participants.
This came after the drug major Sun Pharmaceutical presented the Phase-III clinical trial report of the drug Etifoxine HCl Capsule 50 mg for granting manufacture and market permission in the country.
Etifoxine is a benzoxazine class drug primarily used as an anxiolytic, but that also possesses neuroprotective, neuroplastic, and anti-inflammatory properties; these effects are thought to arise due to modulation of GABAergic neurotransmission and neurosteroid synthesis.
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