Drug Approval | October 05, 2025
Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection
The NDA submission follows the successful completion of a pivotal Phase III global clinical trial
The NDA submission follows the successful completion of a pivotal Phase III global clinical trial
This milestone marks the first-ever NDA submission to the U.S. FDA for a drug, fully discovered and developed by an Indian pharmaceutical company
With just few days of treatment, the patient started responding well and finally complete clinical resolution of infection was attained
This case report is jointly authored by US clinicians from leading hospitals, Houston Methodist Hospital, Weill Cornell Medical College and Johns Hopkins
The overall clinical efficacy of Zaynich across indications was 98% at the test-of-cure
In the US, the compassionate use approvals are provided by FDA in the form of individual patient-specific expanded-access IND
WCK 6777 is the only once-a-day drug in global antibiotic pipeline designed for outpatient parenteral antimicrobial therapy
A multi-disciplinary team of senior physicians opted to use Zidebactam/Cefepime under compassionate use
The USFDA has granted a qualified infectious disease product (QIDP) designation to WCK 6777, which signifies its ability to meet unmet medical needs and facilitates a faster approval process
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