Sun Pharma Laboratories Gets CDSCO Panel Nod for Etifoxine Hydrochloride Capsules study

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-12-28 12:30 GMT | Update On 2024-12-28 12:30 GMT

New Delhi: Pharmaceutical major Sun Pharma Laboratories has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct an active Post-Marketing Surveillance (PMS) study with Etifoxine Hydrochloride Capsules 50 mg.

This came after Sun Pharma Laboratories presented an active PMS study protocol with drug Etifoxine Hydrochloride Capsules 50 mg before the committee.

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 an anxiolytic and anticonvulsant drug. It is used in anxiety disorders and to promote peripheral nerve healing. It does not bind to the benzodiazepine receptor, though the effects are similar to that of benzodiazepines.

At the recent SEC meeting for Neurology and Psychiatry held 12th December 2024, the expert panel reviewed the active PMS study protocol of Etifoxine Hydrochloride Capsules 50mg.

After detailed deliberation, the committee recommended the grant of permission to conduct active PMS study with new drug Etifoxine Hydrochloride Capsules 50mg as per the protocol presented.

Also Read:BDR Pharmaceuticals Gets CDSCO Panel Nod for bioequvalence study of Abiraterone Acetate Oral Suspension

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Dr. Divya Colin

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.

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Sun Pharma Laboratories Gets CDSCO Panel Nod for Etifoxine Hydrochloride Capsules study

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