- Table 1 of the draft package insert is based on Table 5.3.2 of the updated Integrated Summary of Safety (ISS). They contain information inconsistent with “AE Symp” of the xae.xpt dataset, because the coding of preferred terms (PT) has underestimated the occurrence of some clinical manifestations in “AE Symp”. For instance, the PT list has not included cases --------------------------(b)6)----------------------- for “intubation” and cases --------(b)(6)-------- for pneumonia, aspiration. We request that you conduct a comprehensive review of your coding for preferred terms and reconcile any inconsistencies between AE symp and PT so that Table 5.3.2 of the ISS can be revised and Table 1 of the draft label can accurately reflect the actual data obtained.
- In the studyrx.xpt data set there are 1535 patients listed. However, Table 1 of the draft package insert indicates there were only 1534 patients exposed to Anascorp. Please identify the patient not exposed to Anascorp and explain why the patient was not exposed.
- Based on the data set xae.xpt, there were 428 patients who experienced at least one adverse event. In Table 1 of the draft package insert, the corresponding number is 421. Also, your numbers of patients who experienced Vomiting, Pyrexia and Nausea in Table 1 are different from that in our calculation (we find 73, 64 and 33, respectively). Please explain these differences.
- In your letter dated April 8, 2009 (submission 125335/0.16), you state, “The sponsor will develop a Pharmacovigilance Standard Operating Procedure (SOP) in conjunction with its United States distributor.” Please advise which amendment contains this SOP or if it has not been submitted yet, please submit this SOP.
- In the original submission, you included a draft container (vial) and carton (package) label. Please provide a revised draft of these labels that accurately reflects the format (color, font, dimensions, etc.) of the labels as they are intended for use. For the carton, please provide a draft version that depicts all sides, top and bottom of the carton so FDA can evaluate the placement of the information as it will appear when marketed. Please submit this in electronic format, .pdf, or as an image, .jpeg, in the SPL.