Lupin receives USFDA approval for Prucalopride Tablets
Prucalopride Tablets are indicated for the treatment of chronic idiopathic constipation in adults
Prucalopride Tablets are indicated for the treatment of chronic idiopathic constipation in adults
Bonthapally facility is one of the world's largest single-site Paracetamol API manufacturing plants by volume
The company will provide the necessary response to USFDA within stipulated 15 days
The company received seven observations in the Form-483
Sun Pharma gets 8 observations from USFDA for Halol facility
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
Zydus receives EIR for the API manufacturing facility at Ankleshwar
Enflosina is a long-acting monoclonal antibody that provides direct protection for up to 5 months
Oxcarbazepine ER Tablets (RLD Oxtellar XR) had estimated annual sales of US$ 206 million in the US (IQVIA MAT April 2025)
Aumolertinib can be used in patients who have tested positive for a mutation in a gene called epidermal growth factor receptor
Rifaximin tablets had annual sales of US$ 2672.9 mn in the United States (IQVIA MAT March 2025)
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
This is specifically for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition
Usnoflast has previously also received ‘Orphan Drug Designation (ODD)’ from the USFDA
Allopurinol is used to prevent or lower high uric acid levels in the blood
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