Nevakar, Inc. – FDA CRL

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Nevakar, Inc. for its New Drug Application (NDA 214628) concerning Norepinephrine Bitartrate in Sodium Chloride Injection, filed under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The FDA cannot approve the application in its current state due to several critical issues. A primary concern involves deficiencies identified during a recent inspection of Nevakar's manufacturing facility, which require satisfactory resolution. Additionally, the FDA noted further Chemistry, Manufacturing, and Controls (CMC) deficiencies relevant to any resubmission. While labeling comments are deferred, the agency instructed Nevakar to review labeling resources. Crucially, a comprehensive safety update is mandated per 21 CFR 314.50(d)(5)(vi)(b). This update must detail any significant changes in the drug's safety profile, integrate all new safety data, retabulate adverse event frequencies, and provide case reports for patient deaths or discontinuations due to adverse events. Nevakar must fully address these deficiencies and resubmit the application within one year under 21 CFR 314.110. The drug cannot be legally marketed until FDA approval is granted.