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EAST WINDSOR, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application chlordiazepoxide hydrochloride and clidinium bromide capsules 5mg/2.5mg. Aurobindo Pharma’s chlordiazepoxide hydrochloride and clidinium bromide capsules are an AB-rated generic equivalent to the reference listed drug (RLD), Librax Capsules manufactured by Bausch Health US.
Chlordiazepoxide hydrochloride and clidinium bromide capsules are indicated to control emotional and somatic factors in gastrointestinal disorders. They are also indicated for adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.
Chlordiazepoxide hydrochloride and clidinium bromide capsules has an estimated market size of US $34 million for the twelve months ending July 2023, as per IQVIA.
