Questa traduzione è in preparazione. Nel frattempo mostriamo temporaneamente la versione originale in inglese.
Imprese · 05/02/20191 min di lettura
Neomycin Sulfate for Prescription Compounding; Withdrawal of Approval of One Abbreviated New Drug Application
Traduzione automatica locale · Lingua originale della fonte
Riepilogo
The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 061579 for nonsterile neomycin sulfate powder for prescription compounding. The basis for the withdrawal is that the product is no longer considered safe as labeled due to clinical evidence that systemic exposure to neomycin sulfate can induce significant toxicity, including ototoxicity (manifested as sensorineural hearing loss), nephrotoxicity, and neuromuscular blockade. The holder of this ANDA has waived its opportunity for a hearing.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →