USFDA approval for Aurobindo Pharma's Hydromorphone Hydrochloride tablets
Source : India Infoline.com
Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Hydromorphone Hydrochloride Tablets USP, 2 mg, 4 mg, and 8 mg.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Dilaudid (hydromorphone hydrochloride) Tablets, 2 mg, 4 mg, and 8 mg of Purdue Pharma L.P. Hydromorphone Hydrochloride Tablets 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 US$ 50 million for the twelve months ending March 2016 according to IMS.
This is the 12 th 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 USFDA.