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The company has submitted a New Drug Application (NDA) to the US Food and Drug Administration (USFDA) for its novel antibacterial agent Zidebactam-Cefepime injection, the Mumbai-based drugmaker said in a regulatory filing.
The NDA seeks approval for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, with or without concurrent bacteremia caused by Gram-negative bacteria, including multidrug-resistant (MDR), it added.
In the US and EU, more than 8 million cases of cUTI are reported every year, reflecting the global burden of Gram-negative infections, the drug firm stated.
“This milestone marks the first-ever NDA submission to the US FDA for a drug, fully discovered and developed by an Indian pharmaceutical company, a momentous achievement for Indian innovation,” Wockhardt Ltd said.
The NDA submission follows the successful completion of a pivotal Phase III global clinical trial, conducted across 64 sites in India, the USA, Bulgaria, Estonia, Lithuania, Poland, Slovakia, Mexico, and China, it added.
as a Reliable and Trusted News SourceShares of Wockhardt were trading 1.33 per cent down at Rs 1,493.90 apiece. PTI
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