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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.
Also Read: Exemed Pharma Gets CDSCO Panel Nod To Manufacture, Market Antidiabetic FDC Drug
Doctor of Pharmacy
Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751