Zydus Cadila gets USFDA nod to market generic Lansoprazole tablets

Written by Medical Dialogues Bureau Published On 2018-12-01T09:05:34+05:30 | Updated On 1 Dec 2018 9:05 AM IST

Zydus Cadila gets USFDA nod to market generic Lansoprazole tablets

New Delhi: Drug firm Zydus Cadila has recently said it has received the 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.

Also Read: Zydus Cadila gets USFDA nod for Baclofen, a muscle spasm treatment tablet

abbreviated new drug applicationsANDAsdisorderLansoprazole tabletsLinagliptin tabletsstomach acidulcersUnited States Food and Drug AdministrationUSFDAZollinger Ellison syndromeZydus Cadila

Source : PTI

Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

Medical Dialogues Bureau

Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers. Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here