Aurobindo Pharma receives USFDA nod for Triamcinolone Acetonide injectable suspension

Aurobindo Pharma Ltd said its arm, Eugia Pharma Specialities Ltd, has received a final approval from the US health regulator to manufacture and market Triamcinolone Acetonide injectable suspension indicated for various conditions, including allergies and rheumatoid arthritis. The approval by the US Food & Drug Administration (USFDA) is for Triamcinolone Acetonide injectable suspension for strengths of 200 mg/5 ml and 400 mg/10 ml, multiple dose vials, the firm said.

The product is being launched this month, it added. It is bioequivalent and therapeutically equivalent to Bristol-Myers Squibb Company's reference listed drug Kenalog-40 injectable suspension, 40 mg/ml, the company said. Citing IQVIA data, Aurobindo said the approved product has an estimated market size of around USD 73 million for the 12 months ended May 2022. Aurobindo said this is the 142nd abbreviated new drug application, including 8 tentative approvals received, out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products.