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Aurobindo gets FDA nod for anti-allergic drug
City-based Aurobindo Pharma on Wednesday said it had received final approval from the US health regulator to manufacture and market its Dexamethasone Sodium Phosphate injection in the American market.
Hyderabad: City-based Aurobindo Pharma on Wednesday said it had received final approval from the US health regulator to manufacture and market its Dexamethasone Sodium Phosphate injection in the American market. The drug is used for the treatment of 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)," the pharma major said in a release.
The company is gearing up to launch the product by fourth quarter of the current fiscal. The approved product has an estimated market size of $31 million for the twelve months ending September 2015, it said, citing IMS. The company's injection is generic equivalent to Luitpold Pharmaceuticals Inc's Dexamethasone Sodium Phosphate injection in the strength of 4 mg/mL
The injection is used in the treatment of various diseases such as severe allergic reactions, arthritis, blood diseases, breathing problems, certain cancers, eye diseases, intestinal disorders and skin ailments. With this, Aurobindp 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.
