近日，FDA发布了对Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC的警告信，主要涉及电子药品注册和上市系统 （eDRLS）/违规行为，其中提及药品注册列名中列出的活性成分的含量与所提交的标签（SPL）内容不一致。此外，还发现主展示版面（即日常销售展示时最可能被用户展现或被查看标签的面）图像上的商品名是 Maximum Strength Nighttime Severe Cold and Flu，但在产品注册列名中列出的名称中，“severe”一词写成了“sever”。

翻译如下：

Section 510(j) of the FD&C Act, 21 U.S.C. 360(j), and 21 CFR Part 207 outline the requirements for registration and listing of drug products. Under 21 CFR 207.49(a)(4), a firm must include in the listing submission to FDA, among other requirements, the name and quantity of each active pharmaceutical ingredient in the listed drug. A review of the listing for Maximum Strength Nighttime Sever Cold and Flu, NDC 68210-4210, reveals that the strength of the active ingredient, doxylamine succinate, does not match between the labeling and the structured product labeling (SPL) sections of the listing submission. Specifically, in the labeling, the strength of the active ingredient, doxylamine succinate, is stated as 6.25 mg however, in the SPL’s basis of strength field, the strength of doxylamine succinate is listed as(b)(4) Additionally, the name in the product listing does not match the name on the product labeling. Specifically, while the proprietary name on the principal display panel image is Maximum Strength Nighttime Severe Cold and Flu, in the listed name, the word “severe” is spelled as “sever.” FD&C 法案第 510（j） 节、21 U.S.C. 360(j)和21 CFR第 207 部分概述了药品注册和列名的要求。根据 21 CFR 207.49（a）（4），除其他要求外，公司必须在向FDA 提交的清单中包含所列药物中每种活性药物成分的名称和数量。对 Maximum Strength Nighttime Severe Cold and Flu 产品信息（NDC 68210-4210）的审核显示，活性成分的含量与所提交产品信息的结构化产品标签（SPL）不一致。具体来说，在标签中，活性成分的含量为 6.25 毫克，但在SPL 的含量字段中，活性成分含量列为（b）（4）。 此外，产品列表中的名称与产品标签上的名称不一致。具体来说，主展示版面图像上的专有名称（商品名）是 Maximum Strength Nighttime Severe Cold and Flu，但在列名中，“severe”一词写成了“sever”。