Aurobindo Pharma arm bags USFDA okay for Triamcinolone Acetonide Injectable Suspension

Hyderabad: Drugmaker, Aurobindo Pharma Limited, has announced that its wholly owned subsidiary company, Eugia Pharma Specialities Limited, has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Triamcinolone Acetonide Injectable Suspension 200 mg/5 mL & 400 mg/10 mL.

Triamcinolone Acetonide Injectable Suspension USP, 200 mg/5 mL (40 mg/mL) Multiple-dose vials and 400 mg/10 mL (40 mg/mL) Multiple-dose vials, to be bioequivalent and therapeutically equivalent to the RLD, Kenalog-40 Injectable Suspension, 40 mg/mL, of Bristol-Myers Squibb Company.

The product is being launched this month. The approved product has an estimated market size of around US$ 73 million forthe twelve months ending May 2022, according to IQVIA. This is the 142nd ANDA (including 8 tentative approvals received) out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products.

Triamcinolone Acetonide Injectable Suspension is in therapeutic Category of Synthetic glucocorticoid corticosteroid and indicated for the treatment of Intramuscular and Intra-Articular use:

• Intramuscular - Where oral therapy is not feasible: allergic states, dermatologic diseases, endocrine disorders, gastrointestinal diseases, hematologic disorders, neoplastic diseases (palliative treatment), nervous system, ophthalmic diseases, renal diseases, respiratory diseases, rheumatic disorders

• Intra-Articular - adjunctive therapy for short-term administration in: acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.