Aurobindo Pharma Limited announced today that the company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Hydromorphone Hydrochloride Tablets USP, 2 mg, 4 mg, and 8 mg.
The product is used to relieve moderate to severe pain in patients where the use of an opioid is appropriate. The approved product has an estimated market size of $50 million for the twelve months ending March 2016, the company said citing the IMS Health data.
The approved ANDA (abbreviated new drug application) is bioequivalent and therapeutically equivalent to the reference listed drug product Dilaudid of Purdue Pharma L P.
This is the 12th ANDA to be approved out of Aurolife formulation facility in New Jersey, USA for manufacturing non-antibiotic products and controlled substances.
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