ARTESUNATE

批准信原文要点

This “Changes Being Effected” supplemental new drug application provides for update to the prescribing information, Section 11 Description section, to reflect the change from the anhydrous form of dibasic sodium phosphate to the dihydrate form.

批准信原文要点

This “Changes Being Effected” sNDA provides for Carton labeling revisions that include: 1. A red box containing the Attention statement, revised to “Attention: Retain vials in carton until time of use...

批准信原文要点

This Prior Approval sNDA provides for revisions to the prescribing information (PI) for the 13 NONCLINICAL TOXICOLOGY section, 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility subsection, Mutagenesis and Fertility subheadings, to include results from nonclinical postmarketing studies including postmarketing requirement (PMR) 3851-3 [A Fertility and Early Embryonic Development Study] and PMR 3851-4 [In Vivo Micronucleus Test of Artesunate in Peripheral Blood of Sprague-Dawley Rats].

批准信原文要点

This “Changes Being Effected” sNDA provides for revisions to the prescribing information (PI) and to carton and container labeling to update the Applicant’s name from Amivas, LLC to Amivas Inc and to update carton and container labeling with the correct National Drug Code (NDC) numbers.

批准信原文要点

This “Changes Being Effected” supplemental new drug application provides for: • Updated labels for Artesunate for injection vial and Diluent vial, and updated carton labeling to include changes to the national drug code (NDC) numbers and global trade item number (GTIN) codes • Updated US Prescribing Information (USPI) for the NDC revisions