Zydus Gets USFDA Nod For Budesonide Delayed-Release Capsules

Regulatory Milestone Strengthens US Portfolio  

Zydus Lifesciences Ltd has announced that it has secured tentative approval from the USFDA for its Budesonide Delayed-Release Capsules, 3 mg. The product is a generic version of Entocort EC, used primarily for the treatment of mild to moderate active Crohn’s disease involving the ileum and/or ascending colon.

The approval allows Zydus to market the product in the US upon expiry of applicable patents or exclusivities. Budesonide is a corticosteroid with potent local anti-inflammatory effects, and the delayed-release formulation ensures targeted delivery in the gastrointestinal tract. The tentative approval reflects Zydus’ continued focus on expanding its complex generics portfolio in regulated markets.

Important Points  

• Zydus receives tentative USFDA approval for Budesonide Delayed-Release Capsules, 3 mg  
• Generic equivalent of Entocort EC, used for Crohn’s disease  
• Approval supports Zydus’ US generics growth strategy  
• Product to be launched post patent expiry  
• Reinforces company’s capabilities in complex formulations  

Sources: USFDA , Business Standard, Zydus Lifesciences Regulatory Filings