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  • Writer's pictureSanjay Trivedi

Zydus receives approval from USFDA for Baclofen Tablets to treat muscle spasms

Zydus Cadila has received the final approval from the USFDA to market Baclofen Tablets (US RLD- Lioresal®) 10 mg and 20 mg. It will be manufactured at the group’s formulations manufacturing facility at Baddi. Baclofen is used to treat muscle spasms caused by certain conditions such as multiple sclerosis, spinal cord injury/disease. It works by helping to relax the muscles. The group now has 234 approvals and has so far filed over 340 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus receives approvals from USFDA for

Lansoprazole Tablets and Linagliptin tablets

Zydus Cadila has received the final approval from the USFDA to market 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 of the stomach that produces acid. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad. 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.

Zydus receives final approval from USFDA

for Teriflunomide Tablets

Zydus Cadila has received the final approval from the USFDA to market Teriflunomide Tablets (US RLD- AUBAGIO), 7 mg and 14 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. Teriflunomide is used to treat relapsing forms of multiple sclerosis (MS). It is not a cure for MS but is thought to work by decreasing certain immune system cells (lymphocytes) which can attack the nerves in brain and spinal cord. This helps decrease the number of flare-ups (relapses) and may help slow down physical problems caused by MS. The group now has 237 approvals and has so far filed over 340 ANDAs since the commencement of the filing process in FY 2003-04.

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