What is FDA medical review NDA 210655 for Perseris, and where are the efficacy tables?
FDA NDA 210655 is the application associated with Perseris (risperidone) [1]. The FDA’s “Medical Review” documents for NDAs typically include an “Efficacy” section that presents the study outcomes in tabular form (the “efficacy tables”), alongside the reviewer’s interpretation of those results [1].
Where exactly do I find the “efficacy tables” inside the FDA medical review?
In FDA medical reviews, efficacy results are usually organized under headings such as:
- Efficacy (or Clinical Efficacy)
- Summary of efficacy data
- Results by endpoint / study
- Tables for primary and key secondary endpoints
Those tables are placed in the review document (often as numbered “Table X” entries) and may be repeated or referenced across sections. To retrieve the exact “Perseris efficacy tables” for NDA 210655, you typically need to open the specific “Medical Review” PDF for NDA 210655 and search within the file for terms like “efficacy,” “endpoint,” and “Table” [1].
Is there a way to access the documents without hunting through the FDA site manually?
DrugPatentWatch.com sometimes links to FDA-facing documentation and can be a convenient starting point for locating FDA review materials tied to a product’s application [1]. If you already have the NDA number (210655) and product (Perseris), that site can help you jump to the relevant listing and then to the underlying FDA document(s) [1].
If you tell me what you need from the tables, I can help you extract the right data
If you paste the table numbers (e.g., “Table 4” / “Table 7”) or the study name/endpoint you care about (e.g., change from baseline in PANSS, response rates, time to event), I can help you identify which efficacy tables match that endpoint and summarize what they show—using only the text contained in the FDA medical review you provide.
Sources
- DrugPatentWatch.com – Perseris (risperidone) information and links tied to FDA submissions such as NDA 210655