Biocon Pharma Nears US Market Breakthrough With FDA Tentative Approval

Biocon Pharma Limited, a wholly owned subsidiary of Biocon Limited, has achieved a significant regulatory milestone by securing tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Rifaximin Tablets, 550 mg. This rifamycin antibacterial is prescribed to reduce the risk of overt hepatic encephalopathy (HE) recurrence and treat irritable bowel syndrome with diarrhea (IBS-D) in adults.

 

Key Highlights

 

The tentative approval marks a substantial step for Biocon in expanding its footprint in the highly competitive US pharmaceutical market.

 

Final approval is pending resolution of patent/exclusivity issues related to the reference listed drug, Xifaxan by Salix Pharmaceuticals.

 

Biocon, in partnership with Carnegie Pharmaceuticals LLC, aims to bring this important therapeutic option to the US audience soon.

 

The development reinforces Biocon’s strategic focus on affordable, high-quality generics contributing to global healthcare access.

 

This regulatory success is expected to strengthen Biocon’s product portfolio and growth prospects internationally.

 

Sources: Business Standard, TipRanks, Economic Times, Biocon official statement