Wockhardt files new drug application with USFDA for antibacterial drug

Drug firm Wockhardt on Wednesday said it has submitted a new drug application for its novel antibacterial drug with the US health regulator.

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.

Shares of Wockhardt were trading 1.33 per cent down at Rs 1,493.90 apiece.