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Aurobindo Pharma Ltd has announced that it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Loperamide Hydrochloride Tablets, 2 mg.
This product is expected to be launched in Q4 FY2015-16.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Imodium® A-D Tablets, 2 mg, of Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division.
Loperamide Hydrochloride Tablet is used to control symptoms of diarrhoea, including travellers’ diarrhoea. The approved product has an estimated market size of $9.7 million for the 12 months ended October 2015, according to IMS.
This is the 53rd ANDA to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing oral non-antibiotic products. Aurobindo now has 223 ANDA approvals (195 final approvals, including 10 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA.
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