May 17 2016, 14.01 PM IST || Pocket News Alert
Aurobindo Pharma Limited, manufacturer of generic pharmaceuticals and active pharmaceutical ingredients, announced on Tuesday that it 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.
Hydromorphone Hydrochloride Tablets is used to relieve moderate to severe pain in patients where the use of an opioid is appropriate, the company release said.
The company said that 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.
Quoting IMS, the company said that the approved product has an estimated market size of US$ 50 million for the twelve months ending March 2016.
The company also said this is the 12th ANDA to be approved out of Aurolife formulation facility in New Jersey, US for manufacturing non-antibiotic products and 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.