Industry

USFDA gives nod for Triamcinolone Acetonide injectable suspension

The approval by the USFDA is for the strengths of 200 mg/5 ml and 400 mg/10 ml, multiple-dose vials.

July 7, 2022

250

Last Updated on October 15, 2024 by The Health Master

New Delhi: Aurobindo Pharma Ltd on Wednesday said its arm, Eugia Pharma Specialities Ltd, has received 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 company 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.

Other drugs approval by USFDA

USFDA gives final approval for Lacosamide Injection

USFDA gives final approval for Seizure injections

USFDA approves Pneumococcal Vaccine for children

USFDA approves this drug for the treatment for weight management

USFDA approves drug for Alopecia, includes safety warning too

USFDA gives tentative nod to Alembic Pharma for Dasatinib tablets

Also read

USFDA issues 2 observations to Cipla Indore Plant

High Court issues notice on plea against Online sale of Medicines

NPPA extends trade margin capping on 5 Medical Devices

Drug recall: Morphine Sulfate 30 mg, 60 mg Extended-Release Tablets recalled due to this reason