Read a drug page
A section-by-section guide to a drug page on the FDA drug record, and how to link to each section.
Every drug page on ephemerisx.com/drugs follows the same layout, so once you have read one you can read them all. A section appears only when the FDA's documents have something for it.
Page layout#
| Section | Link with | What it holds |
|---|---|---|
| Header and facts | – | Brand and generic name, then Sponsor, Application, First approved, Status and Read from. |
| What it is approved for | #indication | The indication, quoted from the label. |
| Trials FDA reviewed | #trials | Each trial the documents discuss. |
| Results FDA reported | #results | Sentences reporting an endpoint's result. |
| Safety | #safety | Boxed warning, common adverse reactions, and the adverse events discussed most. |
| Dosing on the label | #dosing | The label's dosing instructions. |
| FDA documents read | #documents | Every document read, with its fingerprint. |
To link to a section, add its anchor to the page address, for example ephemerisx.com/drugs/kisunla#safety.
Header and facts#
The eyebrow links back to the disease area. Under the drug's name, a strip of facts:
- Sponsor: the applicant.
- Application: for example BLA 761248, linked to Drugs@FDA.
- First approved.
- Status: see Drug status.
- Read from: how many FDA documents and pages the page is built from.
A fact the documents do not give reads not read.
What it is approved for#
The indication, quoted from the label, with its citation.
Trials FDA reviewed#
| Column | Shows |
|---|---|
| Trial | The trial's name, with its protocol code underneath when different. |
| ClinicalTrials.gov | The NCT number, linked to ClinicalTrials.gov, or not given. |
| Phase | Trial phase, where stated. |
| Mentions | How many sentences across the FDA documents name the trial. A rough measure of how central it was to the review. |
| Documents | In how many of the drug's documents it appears, for example 4 of 13. |
NCT numbers are read from the documents. Where the documents give none, the trial is matched on ClinicalTrials.gov by its name or protocol code.
Results FDA reported#
Cards labelled Trial · endpoint. Each quotes a sentence from an FDA review that gives the endpoint's p-value, effect or confidence interval, followed by chips with the numbers it states. Sentences reporting a treatment effect come first.
Safety#
- Boxed warning: quoted from the label, if the drug has one.
- Most common adverse reactions: quoted from the label.
- Adverse events the documents discuss most: a list of adverse events with how many times the documents mention each. It shows what the review focused on, not how often each event happened.
Dosing on the label#
The dosing sentences from the label, quoted with citations.
FDA documents read#
| Column | Shows |
|---|---|
| Document | Title, linked to the file on fda.gov, with the file name underneath. |
| Date | The document's date. |
| Pages | Page count. |
| Copy | An archived copy link to the Internet Archive, when one exists. |
| sha256 | The first 12 characters of the file's fingerprint. Hover for the full value. |
Under the table: the date the page was last checked against the FDA's copies, and whether the page was generated automatically. See Verify a document.