Zydus Cadila generic empagliflozin, linagliptin tablets get tentative USFDA nod
Zydus Cadila Ltd's medication contains a combination of Empagliflozin and Linagliptin, oral diabetes medicines that help control blood sugar levels.
New Delhi: Drug firm Zydus Cadila on Wednesday said it has received approval from the US health regulator to market diabetes drug, Empagliflozin and Linagliptin tablets, in the US market.
The company has received tentative approval from the US Food and Drug Administration (USFDA) to market its generic product, Zydus Cadila said in a statement.
The company has received approval for the product in the strengths of 10 mg/5 mg and 25 mg/5 mg, it added.
This medication contains a combination of Empagliflozin and Linagliptin, oral diabetes medicines that help control blood sugar levels.
The drug is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.
Zydus said the drug will be manufactured at the group''s formulation manufacturing facility at SEZ, Ahmedabad.
The group now has 299 approvals and has so far filed over 390 abbreviated new drug applications (ANDAs) since the commencement of filing process in 2003-04.