Zydus gets USFDA nod for bowel disease drug Balsalazide Disodium

The product will be manufactured at the group’s formulation manufacturing facility in SEZ, Ahmedabad, India.

Published On 2023-06-10 09:47 GMT   |   Update On 2023-06-10 09:47 GMT
Advertisement

Ahmedabad: Zydus Lifesciences Limited has announced that the company has received final approval from the United States Food and Drug Administration (USFDA) for Balsalazide Disodium Capsules USP, 750 mg (USRLD: Colazal Capsules, 750 mg).

Balsalazide Disodium is used to treat bowel diseases like ulcerative colitis. It helps reduce symptoms of ulcerative colitis such as diarrhea, rectal bleeding, and stomach pain. Balsalazide belongs to a class of drugs known as aminosalicylates and works by reducing swelling in the colon.

The product will be manufactured at the group’s formulation manufacturing facility in SEZ, Ahmedabad (India).

Balsalazide Disodium Capsules USP, 750 mg had annual sales of USD 29 mn in the United States (IQVIA MAT April 2023). The group now has 372 approvals and has so far filed over 442* ANDAs since the commencement of the filing process in FY 2003-04.

Read also: Zydus Lifesciences begins Phase IV trial for fatty liver disease drug Saroglitazar Magnesium

Zydus Lifesciences Limited, Formerly known as Cadila Healthcare Limited, is an Indian Pharmaceutical company headquartered in Ahmedabad. The company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals. It is primarily engaged in the manufacture of generic drugs.

Read also: Zydus Lifesciences secures USFDA okay for Esomeprazole Magnesium for Delayed-Release Oral Suspension

Tags:    

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News