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Zinplava Approval History

  • FDA approved: Yes (First approved October 21st, 2016)
  • Brand name: Zinplava
  • Generic name: bezlotoxumab
  • Dosage form: Injection
  • Company: Merck & Co., Inc.
  • 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

DateArticle
Oct 21, 2016Approval FDA Approves Merck’s Zinplava (bezlotoxumab) to Reduce Recurrence of Clostridium difficile Infection
Jul 21, 2016Merck Provides Regulatory Update on Biologics Licensing Application for Investigational Agent Bezlotoxumab
Jun  9, 2016Merck Statement on FDA Advisory Committee Meeting for Zinplava (bezlotoxumab), an Investigational Agent for Prevention of Clostridium difficile Infection Recurrence
Sep 20, 2015Pivotal Phase 3 Studies of Bezlotoxumab, Merck’s Investigational Antitoxin to Prevent Clostridium Difficile Infection Recurrence, Met Primary Endpoint

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