New Delhi: Drug firm Aurobindo Pharma today said it has received final approval of the US health regulator to manufacture and market its Dexamethasone Sodium Phosphate injection, used to treat various conditions such as severe allergic reactions, arthritis and blood diseases.
“The company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dexamethasone Sodium Phosphate injection USP, 4 mg/mL (1 mL, 5 mL and 30 mL vials),” Aurobindo Pharma said in a statement.
The company expects to launch the product by fourth quarter of the current fiscal, it added.
“The approved product has an estimated market size of USD 31 million for the twelve months ending September 2015, according to IMS,” Aurobindo Pharma said.
The company’s injection is generic, equivalent to Luitpold Pharmaceuticals Inc’s Dexamethasone Sodium Phosphate injection in the strength of 4 mg/mL, it added.
Dexamethasone Sodium Phosphate injection is used in the treatment of various conditions such as severe allergic reactions, arthritis, blood diseases, breathing problems, certain cancers, eye diseases, intestinal disorders and skin diseases, the drugmaker said.
The Hyderabad-headquartered company has a total of 220 Abbreviated New Drug Application (ANDA) approvals (192 final approvals, including 10 from Aurolife Pharma LLC and 28 tentative approvals) from the USFDA.