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.
Etifoxine is used for various emotional and bodily reactions followed by anxiety. It is contraindicated in situations such as shock, severely impaired liver or kidney function, and severe respiratory failure. The average dosage is 150 mg per day for no more than 12 weeks.
At the recent SEC meeting for Neurology held on the 12th and 13th of December 2023, the expert panel reviewed the Phase-III Clinical Trial Report of the drug Etifoxine HCl Capsule 50 mg presented by drug major Sun Pharmaceutical.
After detailed deliberation, the committee recommended a grant of permission to manufacture and market Etifoxine HCl Capsule 50 mg for generalized anxiety disorder with somatic symptoms.
In addition, the expert panel suggested that the firm should conduct the post-marketing surveillance (PMS) study with the primary objective of evaluating the drug dependence of Indian subjects.
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