Nov 29: Drug maker Zydus Cadila on Thursday said that it has received the final approval from the USFDA to market its Lansoprazole delayed release orally disintegrating tablets (US RLD- Prevacid), 15 mg and 30 mg and tentative approval for Linagliptin tablets (US RLD- Tradjenta), 5 mg.
“Lansoprazole is in a class of drugs called proton pump inhibitors (PPI) which blocks the production of acid by the stomach. Proton pump inhibitors are used for the treatment of conditions such as ulcers, gastroesophageal reflux disease (GERD) and Zollinger—Ellison syndrome that are caused by stomach acid. Lansoprazole, like other proton-pump inhibitors, blocks the enzyme in the wall ofthe stomach that produces acid. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad,” the company said.
It further said that Linagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad.
The group now has 236 approvals and has so far filed over 340 ANDAs since the commencement of the filing process in FY 2003-04.