Medscape April 3, 2024
Sriparna Roy And Unnamalai L

(Reuters) -The U.S. health regulator approved Basilea Pharmaceutica’s antibiotic for bacterial infections including multidrug-resistant strains, the FDA said on Wednesday.

The Switzerland-based company was seeking approval of its antibiotic ceftobiprole for the treatment of three conditions – Staphylococcus aureus bacteremia (SAB), acute bacterial skin and skin structure infections, and community-acquired bacterial pneumonia.

The approval expands options for patients who may have developed a resistance to currently available antibiotics. More than 2.8 million antimicrobial-resistant infections occur each year in the U.S., according to government data.

The U.S. market for the intravenous antibiotic, which will be sold under the brand name Zevtera, is projected to be $5.50 billion and is probably going to be the “lion’s share of the market for this...

Today's Sponsors

LEK
ZeOmega

Today's Sponsor

LEK

 
Topics: Biotechnology, FDA, Govt Agencies, Pharma, Pharma / Biotech
FDA warns GLP-1 compounder over safety rules
GLP-1 drug approvals: A breakdown
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
FDA approves Novo Nordisk's Ozempic to treat chronic kidney disease in those with diabetes, expanding its use
Certainty vs. speed: How do patients feel about the tradeoff for new cancer drugs?

Share This Article