Reference #: 3008307735 Product: Drugs Recipient: Recipient Name Mr. P. R. Bhaskar Reddy Recipient Title Vice President – Operations Hetero Labs Limited Unit V Surv. No. […]
Recognized Interpretive Criteria Minimum Inhibitory Concentrations(mcg/mL)Broth Microdilutionat 24 Hours Disk Diffusion(zone diameters in mm) Disk Diffusion at 24 Hours Pathogen S I R S I R […]
This web page provides information about the in vitro susceptibility of fungi to certain drugs. The safety and efficacy of these drugs in treating clinical infections due […]
Intelence (etravirine) In combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients who have evidence of viral replications and HIV-1 […]
This listing includes accelerated approvals (AAs) for non-malignant hematological, neurological, and other disorder indications with postmarketing trials that have verified clinical benefit and for which traditional approval has been […]
This listing includes accelerated approvals (AAs) for infectious disease indications that have postmarketing requirement(s) that have been subsequently withdrawn, and are therefore, no longer FDA-approved. Withdrawn indications are not […]
This listing includes accelerated approvals (AAs) for infectious disease indications with postmarketing trials that have verified clinical benefit and for which traditional approval has been subsequently granted for the […]
This listing includes accelerated approvals (AAs) for infectious disease indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit. Please refer to [email protected] for the latest approvals and […]
Skysona (elivaldogene autotemcel) Indicated to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (cald) 9/16/2022 PMR 1: […]
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