Generic Drug Approval Secured for Type 2 Diabetes Treatment in the US
Zydus Lifesciences Receives Tentative USFDA Clearance for Empagliflozin and Linagliptin Tablets
A pharmaceutical company has announced that it secured tentative approval from the United States Food and Drug Administration (USFDA) for tablets containing the combination of empagliflozin and linagliptin.
-
Strengths: The tablets will be available in strengths of 10 mg/5 mg and 25 mg/5 mg, matching the reference tablets.
-
Indication: The empagliflozin and linagliptin combination is utilized as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both active ingredients is appropriate.
-
Manufacturing: The company intends to manufacture these tablets at its formulation manufacturing facility located in the Special Economic Zone (SEZ) in Ahmedabad.
Economic Context and Business Performance:
-
The empagliflozin and linagliptin combination tablet represents a substantial market, recording annual sales of $215.8 Million in the United States for the period ended September 2025 (according to IQVIA MAT data).
-
With this approval, the group has now secured a total of 428 approvals and has filed 487 Abbreviated New Drug Applications (ANDAs) since the start of its filing process in FY2003-04.
-
Regarding business performance, the company reported a net profit of ₹1,259 Crore (approximately 12.59 billion Indian Rupees) for the quarter ended September 2025. This figure was 39% higher year-on-year compared to the ₹911 Crore (approximately 9.11 billion Indian Rupees) reported in the previous corresponding period.
