Abbott received permission from the Subject Expert Committee to market a fixed dose combination (FDC) of Lidocaine and Diltiazem, after detailed deliberation by committee.
Abbott has presented a Phase III clinical trial report before the committee and after detailed deliberation, the committee recommended grant of permission for manufacturing and marketing of the proposed FDC.
Diltiazem and lidocaine are important medications in the treatment of anal fissures. Diltiazem relaxes the anal sphincter to aid in the healing process. Lidocaine provides pain relief by numbing the skin.
At the 46th meeting of SEC for Gastroenterology & Hepatology, dated 16.03.2022, the expert panel reviewed the report of Phase 3 Clinical Trial of Lidocaine 2% plus Diltiazem hydrochloride 2% Gel and recommended grant of permission for manufacturing and marketing
