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December 2, 2022

Hetero Labs Limited Unit V – 520359 – 11/29/2022

Reference #: 3008307735 Product: Drugs Recipient: Recipient Name Mr. P. R. Bhaskar Reddy Recipient Title Vice President – Operations Hetero Labs Limited Unit V Surv. No. […]
December 1, 2022

Caspofungin Injection

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 […]
December 1, 2022

Antifungal Susceptibility Test Interpretive Criteria

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 […]
December 1, 2022

Verified Clinical Benefit | Infectious Disease Accelerated Approvals (excluding vaccines)

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 […]
December 1, 2022

Verified Clinical Benefit | Non-malignant Hematological, Neurological, and Other Disorder Indications Accelerated Approvals

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 […]
December 1, 2022

Withdrawn | Infectious Disease Accelerated Approvals

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approvals (AAs) for infectious disease indications that have postmarketing requirement(s) that have been subsequently withdrawn, and are therefore, no longer FDA-approved. Withdrawn indications are not […]
December 1, 2022

Verified Clinical Benefit | Infectious Disease Accelerated Approvals Vaccines

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 […]
December 1, 2022

Ongoing | Infectious Disease Accelerated Approvals (excluding vaccines)

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 […]
December 1, 2022

Ongoing | Non-malignant Hematology, Neurological Disorders, and Other Indications Accelerated Approvals

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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