Sun Pharma gets CDSCO panel nod to manufacture, and market Etifoxine HCL capsules for anxiety
New Delhi: The drug major Sun Pharmaceuticals has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) manufacture and market Etifoxine HCl Capsule 50 mg for generalized anxiety disorder with somatic symptoms.
In addition to the above, the expert panel suggested the firm conduct the post-marketing surveillance (PMS) study with the primary objective of evaluating the drug dependence of Indian subjects.
This came after the drug major Sun Pharmaceuticals presented a Phase-III clinical trial report of the drug Etifoxine HCl Capsule 50 mg for grant of 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.
Etifoxine has a dual mechanism of action on GABAergic transmission, through both a direct effect on the GABA receptor and an indirect effect via neurosteroid synthesis allowing for allosteric modulation of the GABAA receptor.
At the recent SEC meeting for neurology and psychiatry, the expert panel reviewed the Phase-III clinical trial report of the drug Etifoxine HCl Capsule 50 mg presented by Sun Pharmaceuticals.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market Etifoxine HCl Capsule 50 mg for generalized anxiety disorder with somatic symptoms.
Furthermore, the expert panel stated that the firm should conduct the post-marketing surveillance (PMS) study with primary objective of evaluating the drug dependence of Indian subjects.
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