Zydus Cadila gets USFDA nod for Empagliflozin & Linagliptin tablets

Zydus Cadila informed the exchanges on Wednesday that it has received tentative approval from United States Food & Drug Administration (USFDA) to market Empagliflozin and Linagliptin tablets (US RLD: Glyxambi tablets) in the strengths of 10 mg/5 mg and 25 mg/5 mg.

This medication contains a combination of Empagliflozin and Linagliptin, which are oral diabetes medicines that help in controlling blood sugar levels. The two medicines are used together with diet and exercises to improve blood sugar control in adults with type 2 diabetes mellitus. The drug will be manufactured at the group’s formulation manufacturing facility at SEZ, Ahmedabad.

Empagliflozin and Linagliptin tablets, 10 mg/5 mg, and 25 mg/5 mg had annual sales of approximately US$ 242 million in the US (IQVIA MAT March 2020).

Zydus Cadila is a pharmaceutical company that discovers, develops, manufactures, and markets a broad range of healthcare therapies including small molecule drugs, biologic therapeutics, and vaccines. The group now has 299 approvals and has so far, filed over 390 ANDAs since the commencement of the filing process in FY 2003-04.

At 3.29 pm on Wednesday, the stock of Cadila Healthcare was trading at Rs 370.80 per share, up by 1.81 per cent or Rs 6.60 per share on BSE, against a 0.45 per cent decline in the benchmark index. The 52-week high is recorded at Rs 411.60 and the 52-week low is Rs 212.70 on BSE.