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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 loperamide hydrochloride capsules USP, 2mg. Aurobindo Pharma’s loperamide hydrochloride capsules are an AB-rated generic equivalent to the reference listed drug (RLD), Imodium Capsules, manufactured by Johnson and Johnson Consumer Inc., McNeil Consumer Healthcare Division.
Loperamide hydrochloride capsules are indicated for the control and symptomatic relief of acute nonspecific diarrhea in patients 2 years of age and older and of chronic diarrhea in adults associated with inflammatory bowel disease. They are also indicated for reducing the volume of discharge from ileostomies.
Loperamide hydrochloride capsules has an estimated market size of US $21.8 million for the twelve months ending June 2023, as per IQVIA.
