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