India, Jan. 7 -- Wockhardt has successfully filed a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) for its novel antibiotic WCK 5222 on January 5, 2026.
The EMA is the central regulatory authority responsible for the scientific evaluation of new medicines across 27 European Union (EU) member states and three European Economic Area (EEA) countries—Iceland, Liechtenstein, and Norway—covering a total of 30 countries.
Earlier, the EMA had informed Wockhardt that WCK 5222, a fixed-dose combination of Zidebactam (1 g) and Cefepime (2 g), is eligible for Accelerated Assessment. This regulatory pathway enables a shortened review timeline, recognising the significant unmet medical need addressed by t...