This first joint plan on One Health aims to create a framework to integrate systems and capacity so that we can collectively better prevent, predict, detect, and respond to health threats
Extended Phenytoin Sodium Capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures
68% of children on a higher dose of Dupixent achieved histological disease remission at week 16
Acquisition brings leading sickle cell disease portfolio and pipeline to Pfizer with potential to address critical needs in an underserved patient community
Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
The product will be manufactured at Lupin's facility in Nagpur, India.
The inspection concluded with no observation (FDA-483) issued.
Amantadine Extended-Release capsules had annual sales of US $2.7 million in the United States according to IQVIA data
Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urinary incontinence, urgency, and frequency
The inspection of the facility was conducted from August 16-19, 2022.
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