Drug Approval | September 08, 2025
USFDA conducts product specific pre-approval inspection at Lupin’s Aurangabad facility
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
Zydus will work closely with the USFDA to address and resolve the observations in an expeditious manner
Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure
At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported
The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations
Macitentan tablets are an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension
The inspection concluded with NIL observations
Rivaroxaban is used to treat venous thromboembolism
Diltiazem works by relaxing blood vessels, which reduces the workload on the heart and increases blood and oxygen supply to the heart muscle
Prucalopride is prescribed for chronic idiopathic constipation
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