Zydus Pharma gets USFDA nod for Eluxadoline Tablets
Ahmedabad: Zydus Cadila today announced that the company's U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received tentative approval from the United States Food and Drug Administration (USFDA) to market Eluxadoline Tablets in the strengths of 75 mg and 100 mg (US RLD: VIBERZI Tablets).
Zydus' Eluxadoline Tablets are indicated in adults for the treatment of irritable bowel syndrome with diarrhea, or IBS-D.
The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad. The group now has 324 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.
Read also: Zydus Cadila bags USFDA nod for Glycopyrrolate Injection
Zydus Cadila is a global pharmaceutical company headquartered in Ahmedabad, India.
The company discovers, develops, manufactures, and markets a broad range of healthcare therapies.
Read also: Zydus randomises 'first patient' in phase 2 trial of Saroglitazar Mg in NASH
