Aurobindo gets USFDA nod for multi disease treatment injection

Drug firm Aurobindo Pharma  has received final approval of the US health regulator to manufacture and market its Dexamethasone Sodium Phosphate injection. The drug is used to treat various conditions such as severe allergic reactions, arthritis and blood diseases. The approved product has an estimated market size of USD 31 million for the twelve months ending September 2015. 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 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.


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