Innoviva Specialty Therapeutics Launches ZEVTERA For U.S. Market

(RTTNews) - Innoviva Specialty Therapeutics Inc., a subsidiary of Innoviva, Inc. (INVA), announced the United States commercial availability of ZEVTERA (ceftobiprole medocaril sodium for injection).

The company noted that ZEVTERA is the only U.S. Food and Drug Administration approved advanced-generation cephalosporin indicated to treat adult patients with Staphylococcus aureus bloodstream infection (bacteremia) (SAB), including those with right-side endocarditis caused by methicillin-susceptible and methicillin-resistant isolates.

In April 2024, the U.S. FDA approved ZEVTERA for three indications.It is the only FDA-approved MRSA cephalosporin antibiotic for treating adult patients with SAB and right-side endocarditis. In addition to Staphylococcus aureus bacteremia, ZEVTERA is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections, and adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia.

ZEVTERA was developed by Basilea Pharmaceutica Ltd, Allschwil ("Basilea") and received Priority Review, Fast Track, and Qualified Infectious Disease Product designations for the CABP, ABSSSI, and SAB indications. In December 2024, Innoviva Specialty Therapeutics, Inc., acquired exclusive U.S. marketing rights through a licensing agreement with Basilea.

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