Zydus Cadila gets USFDA nod for generic drugs

The company has received final approval from the US Food and Drug Administration (USFDA) for the medication in 300 mg strength, Zydus Cadila said in a statement

New Delhi: Drug firm Zydus Cadila on Saturday said it has received approval from the US health regulator to market Ursodiol capsules, used to treat primary biliary cirrhosis, in America.

The company has received final approval from the US Food and Drug Administration (USFDA) for the medication in 300 mg strength, Zydus Cadila said in a statement. Ursodiol is in a class of medications called gallstone dissolution agents. It is used to treat people with primary biliary cirrhosis, an autoimmune liver disease.

The company said it has also received tentative approval from USFDA to market Linagliptin and Metformin Hydrochloride tablets in multiple strengths. The medication is used along with diet and exercise to improve control of blood sugar levels in adults with type 2 diabetes mellitus.

Both drugs will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad, Zydus Cadila said. The Ahmedabad-based group now has 307 approvals and has so far filed over 390 Abbreviated New Drug Applications (ANDAs) since the commencement of the filing process in 2003-04.