NEW DELHI, Nov 29:Drug firm Zydus Cadila Thursday said it has received final nod from the US health regulator to market generic Lansoprazole tablets used for treating conditions caused by stomach acid.
The final approval from the United States Food and Drug Administration (USFDA) is to market Lansoprazole delayed release orally disintegrating tablets in the strengths of 15 mg and 30 mg, Zydus Cadila said in a statement.
The product “will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad,” it added.
Lansoprazole tablets are used for the treatment of conditions such as ulcers, gastroesophageal reflux disease (GERD) and Zollinger-Ellison syndrome that are caused by stomach acid, Zydus Cadila said.
The company has also received tentative approval from the USFDA for generic Linagliptin tablets in the strength of 5 mg, it added.
Linagliptin tablets will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad, Zydus Cadila said.
The product is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, it added.
The group now has 236 approvals and has so far filed over 340 abbreviated new drug applications (ANDAs) since the commencement of its filing process, Zydus Cadila said.
(PTI)
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