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US FDA approves Basilea Pharmaceutica's antibiotic

By Reuters   |   Apr 3, 2024 at 03:59 PM EST
US FDA approves Basilea Pharmaceutica's antibiotic

(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) as well as 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 the Centers for Disease Control and Prevention.

The intravenous drug, which will be sold under the brand name Zevtera in the U.S, is an advanced-generation cephalosporin antibiotic, and works against a wide range of Gram-positive bacteria including methicillin-resistant strains, and Gram-negative bacteria.

(Reporting by Sriparna Roy, Unnamalai L and Christy Santhosh in Bengaluru; Editing by Vijay Kishore)

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