Cipla proposal to market Plazomicin with clinical trial waiver rejected by CDSCO panel
New Delhi: Rejecting pharma major Cipla's proposal to import and market Plazomicin 50mg/ml injection with a local clinical trial waiver, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has opined the firm to conduct a Phase III clinical trial in the country and accordingly submit the Phase III clinical trial protocol to CDSCO for further review.
This came in the wake of the proposal presented by the firm to import and marketing of Plazomicin 50mg/ml injection with local clinical trial waiver before the committee.
Plazomicin is a parenterally administered, broad spectrum aminoglycoside antibiotic typically used for moderate-to-severe urinary tract infections or pyelonephritis.
Plazomicin mediates the antibacterial activity against pathogens including carbapenem-resistant (CRE) and extended-spectrum beta-lactamase (ESBL) producing Enterobacteriaceae. It mediates the antibacterial activity by binding to bacterial 30S ribosomal subunit and inhibiting protein synthesis Label.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.