Aurobindo Pharma receives US FDA nod for hydromorphone tablet

Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market pain-reliever drug hydromorphone hydrochloride tablet (2 mg, 4 mg, and 8 mg). The approved tablet is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Dilaudid of Purdue Pharma LP.
 
Hydromorphone hydrochloride tablet, used to relieve moderate to severe pain in patients where the use of an opioid is appropriate, has an estimated market size of $ 50 million for the twelve months ending March 2016, according to IMS.
 
This is the 12th ANDA to be approved out of Aurolife formulation facility in New Jersey, USA for manufacturing non-antibiotic products & controlled substances. Aurobindo now has a total of 263 ANDA approvals (225 final approvals including 12 from Aurolife Pharma LLC and 38 tentative approvals) from US FDA.