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Wockhardt Submits NDA for Novel Antibiotic to U.S. FDA

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Wockhardt Submits NDA for Novel Antibiotic to U.S. FDA

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Wockhardt Limited ( (IN:WOCKPHARMA) ) has issued an update.

Wockhardt Limited has submitted a New Drug Application to the U.S. FDA for Zidebactam-Cefepime (WCK 5222), a novel antibacterial agent designed to treat serious Gram-negative infections, including complicated urinary tract infections. This submission is a significant milestone as it represents the first-ever NDA submission by an Indian pharmaceutical company for a drug fully discovered and developed in India. The drug, which has shown efficacy against multi-drug resistant pathogens, has been granted qualified infectious disease product and Fast Track Designation by the US FDA, highlighting its potential impact on addressing antimicrobial resistance globally.

More about Wockhardt Limited

Wockhardt Limited is an Indian pharmaceutical company engaged in the development and manufacturing of pharmaceutical and biopharmaceutical formulations. The company focuses on producing novel drugs, particularly in the field of antibiotics, to address unmet medical needs and combat drug-resistant infections.

Average Trading Volume: 39,524

Technical Sentiment Signal: Buy

Current Market Cap: 254.4B INR

Learn more about WOCKPHARMA stock on TipRanks’ Stock Analysis page.

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