Zydus receives USFDA tentative approval for Budesonide delayed-release capsules

Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for Budesonide delayed-release capsules, 4 mg (USRLD: Tarpeyo Capsules, 4 mg).

Budesonide is indicated for mild to moderate active Crohn's disease involving the ileum and/or the ascending colon in adults and children 8 years of age and older. Budesonide capsules will be produced at is Zydus Pharmaceuticals Ltd, SEZ-II.

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