Drug Approval | June 17, 2025
USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad
The company received one observation in the Form-483
The company received one observation in the Form-483
The inspection concluded successfully, with the facility found to be in compliance with the required regulations
Now approved for both acute and chronic HCV in adults and children aged 3 and above
The company received 1 (One) observation in the Form-483
Oxcarbazepine ER Tablets (RLD Oxtellar XR) had estimated annual sales of US$ 206 million in the US (IQVIA MAT April 2025)
If approved, linerixibat could address high unmet medical need of patients living with cholestatic pruritus (relentless itch) and related sleep interference
Rifaximin tablets had annual sales of US$ 2672.9 mn in the United States (IQVIA MAT March 2025)
Revvity launches its first set of IVD Mimix reference standards, providing diagnostic labs with trusted quality controls for optimizing tests and monitoring workflows
Pivotal results from the Phase 3 Breakwater trial showed 51% risk reduction in death compared to standard-of-care treatment
The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial where OS did not meet statistical significance
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