Abbott Gets SEC Nod to Market Chlordiazepoxide Tablets for Anxiety, Alcohol Withdrawal
New Delhi: Abbott Healthcare has received approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market the Chlordiazepoxide Tablets IP 15 mg and 20 mg (Intermediate strengths) for anxiety disorders, withdrawal symptoms of acute alcoholism and preoperative apprehension and anxiety.
This came after the Bioequivalence clinical study report of Chlordiazepoxide Tablets IP 20 mg before the committee.
Chlordiazepoxide is in a class of medications called benzodiazepines. It works by decreasing abnormal electrical activity in the brain. Chlordiazepoxide is used to relieve anxiety and to control agitation caused by alcohol withdrawal.
Chlordiazepoxide has anti-anxiety, sedative, appetite-stimulating, and myorelaxant actions. The medication binds to benzodiazepine receptors at the gamma-aminobutyric acid type A (GABA-A) ligand-gated chloride channel complex and enhances GABA's inhibitory effects.
At the recent SEC meeting for Neurology and Psychiatry held on 18th June 2025, the expert panel reviewed the Bioequivalence clinical study report of Chlordiazepoxide Tablets IP 20 mg before the committee.
After detailed deliberation, the committee recommended to accept the BE study report and for grant of permission to manufacture & marketing of Chlordiazepoxide Tablets IP 15 mg and 20 mg (Intermediate strengths) for anxiety disorders, withdrawal symptoms of acute alcoholism and preoperative apprehension and anxiety.
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