Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Merck’s C. Diff Drug Zinplava Clears FDA With Heart Failure Warning

Executive Summary

Following panel recommendation, label includes warning of use of bezlotoxumab in patients with history of congestive heart failure; postmarketing commitments include studies on microbial retention and endotoxin recovery.

Advertisement

Related Content

Antibiotic Pipeline Profile: Narrowing The Spectrum Of Drug Activity
Seres Argues Different Diagnostic Needed In Recurrent C. Difficile Trials
Keeping Track: Merck's Winning Week; Novel Agents Submitted By GSK, Melinta, Portola
FDA's NDA And BLA Approvals: Vermox, Zinplava
Merck & Co Expands C Diff Franchise With US Zinplava Approval
C.Diff Unmet Need Overcomes Bezlotoxumab Panel's Efficacy Concerns
Merck Went Own Way On Bezlotoxumab Endpoint And FDA May Not Follow

Topics

Related Companies

Related Deals

Advertisement
UsernamePublicRestriction

Register

PS119391

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

All set! This Question has been sent to my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel