Wockhardt Secures Approval for New Antibiotic Zaynich in India
Wockhardt Ltd has obtained authorization from India's drug regulator, CDSCO, to market its newly developed antibiotic Zaynich. The drug targets complicated urinary tract infections, offering an effective alternative to existing treatments, and has shown promising results in pivotal clinical trials.
- Country:
- India
Pharmaceutical company Wockhardt Ltd has announced receiving the green light from the Central Drugs Standard Control Organisation (CDSCO) to import and market Zaynich, a novel antibiotic developed indigenously in India. The medication comes in a combination of Zidebactam and Cefepime.
Zaynich is approved for treating adults suffering from complicated urinary tract infections (cUTIs), including pyelonephritis, and for cases with concurrent Gram-negative bacteremia. This approval is founded on robust results from the ENHANCE-1 Phase 3 clinical trial, which demonstrated its efficacy compared to meropenem in treating such infections. The Clinical and Laboratory Standards Institute has acknowledged the drug's broad-spectrum capabilities, endorsing its potential against extensively drug-resistant pathogens.
(With inputs from agencies.)
- READ MORE ON:
- Wockhardt
- CDSCO
- Zaynich
- antibiotic
- India
- cUTI
- Zidebactam
- Cefepime
- ENHANCE-1
- approval
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