Trial Profile
A Randomized, Double-blind, Multicenter Study to Establish the Safety and Efficacy of Ceftobiprole Medocaril Compared With Vancomycin Plus Aztreonam in the Treatment of Acute Bacterial Skin and Skin Structure Infections
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 08 Apr 2024
Price :
$35
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At a glance
- Drugs Ceftobiprole medocaril (Primary) ; Aztreonam; Vancomycin
- Indications Bacterial infections; Skin and soft tissue infections
- Focus Registrational; Therapeutic Use
- Acronyms TARGET
- Sponsors Basilea Pharmaceutica
- 04 Apr 2024 According to a Basilea Pharmaceutica media release, the US FDA approved ZEVTERA (ceftobiprole medocaril sodium for injection), for the treatment of adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis, and adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP).
- 02 Oct 2023 According to a Basilea Pharmaceutica media release,company announced that the US FDA has accepted filing of the NDA for ceftobiprole supported by clinical efficacy and safety data from the phase 3 studies ERADICATE, TARGET &CABP.3 seeking approval for treating patients in Staphylococcus aureus bacteremia,right-sided infective endocarditis,acute bacterial skin and skin structure infections &community-acquired bacterial pneumonia. The FDA has set April 03, 2024, as PDUFA goal date.
- 04 Aug 2023 According to a Basilea Pharmaceutica media release, company announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA). The NDA submission includes clinical efficacy and safety data from the phase 3 studies ERADICATE (SAB), TARGET (ABSSSI), and a phase 3 study in CABP.