Zydus Lifesciences gets FDA final approval for Balsalazide Disodium Capsules

Zydus Lifesciences, along with its subsidiaries and affiliates, has achieved a significant milestone with the final approval from the US Food and Drug Administration (FDA) for Balsalazide Disodium Capsules USP, 750 mg (known as Colazal Capsules, 750 mg in the US market).

Balsalazide Disodium is a medication primarily used to treat bowel diseases such as ulcerative colitis. It effectively alleviates symptoms associated with ulcerative colitis, including diarrhea, rectal bleeding, and stomach pain.

Belonging to the class of drugs called aminosalicylates, Balsalazide works by reducing inflammation in the colon. The formulation of the product will take place at Zydus’ formulation manufacturing facility in SEZ, Ahmedabad, India.

The US market presents a significant opportunity for Balsalazide Disodium Capsules USP, 750 mg, as the product had recorded annual sales of $29 million as of IQVIA MAT April 2023. This approval further strengthens Zydus Lifesciences‘ product portfolio and positions the company for growth in the competitive US pharmaceutical market.

Zydus Lifesciences receives FDA approval for Balsalazide Disodium Capsules to treat ulcerative colitis. Photo courtesy of Zydus Cadila.

Zydus Lifesciences has emerged as a prominent player in the pharmaceutical industry with a robust track record of regulatory approvals. With this latest approval, the group’s tally reaches an impressive 372 approvals. Since the initiation of the filing process in the fiscal year 2003-04, Zydus has filed over 442 Abbreviated New Drug Applications (ANDAs), reflecting its commitment to delivering quality healthcare solutions to patients worldwide.

The approval from the FDA for Balsalazide Disodium Capsules USP, 750 mg underscores Zydus’ dedication to expanding its presence in the global pharmaceutical market and addressing the unmet medical needs of patients suffering from ulcerative colitis. By continually pursuing innovation and stringent quality standards, Zydus aims to enhance the lives of patients and contribute to the advancement of healthcare worldwide.