This is the first time in history that an NDA for a New Chemical Entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the USFDA
This case report is jointly authored by US clinicians from leading hospitals, Houston Methodist Hospital, Weill Cornell Medical College and Johns Hopkins
Such combined efficacy (achieving clinical cure and microbiologic cure) of Zaynich is highest ever among all the FDA-approved novel antibiotics developed in the last more than 10 years
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
A multi-disciplinary team of senior physicians opted to use Zidebactam/Cefepime under compassionate use
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
EBITDA for Q1 FY25 is at Rs. 100 crore compared to Rs. 32 crore in the previous year
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