Zinplava Approval History
FDA Approved: Yes (First approved October 21, 2016)
Brand name: Zinplava
Generic name: bezlotoxumab
Dosage form: Injection
Treatment for: Prevention of Clostridium Difficile Infection Recurrence
Zinplava (bezlotoxumab) is a selective, fully-human, monoclonal antibody that binds to Clostridium difficile toxin B, indicated to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older.
Zinplava is administered as a single dose intravenous infusion over 60 minutes during antibacterial drug treatment for CDI.
In clinical trials, heart failure was reported more commonly in Zinplava-treated patients with a history of congestive heart failure, and it recommended that patients with a history of CHF should only receive Zinplava when the benefit outweighs the risk. Common side effects include nausea, fever, and headache.
Development History and FDA Approval Process for Zinplava
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