Aurobindo Pharma has received final approval from the US health regulator to manufacture and market opioid analgesic Hydromorphone Hydrochloride tablets in the American market.
“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,” Aurobindo Pharma said in a BSE filing.
The approved product is a generic version of Purdue Pharma’s Dilaudid tablets in the same strengths, it added.
According to IMS, the product has an estimated market size of $50 million for the 12 months ended March, Aurobindo Pharma said.
Hydromorphone Hydrochloride tablets are used to relieve moderate to severe pain in patients where the use of an opioid is appropriate, it added.
The company has 263 Abbreviated New Drug Application (ANDA) approvals (225 final approvals including 12 from Aurolife Pharma LLC and 38 tentative approvals) from the USFDA.
Shares of Aurobindo Pharma were trading 0.56 per cent down at Rs 784.80 on the BSE in the afternoon session.