Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Loperamide Hydrochloride Tablet, 2 mg. This product is expected to be launched in Q4 FY2015-16.
[adsense:336x280:8701650588]
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 diarrhea, including Travelers’ diarrhea. The approved product has an estimated market size of US$9.7 million for the twelve months ending October 2015 according to IMS.
[adsense:468x15:2204050025]
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 a total of 223 ANDA approvals (195 Final approvals including 10 from Aurolife Pharma LLC and 28 Tentative approvals) from USFDA.
