FDA label actions · negotiated drugs
Recent label changes on Medicare negotiated drugs
Every non-manufacturing FDA label action dated since November 11, 2025 on the drugs in Medicare's negotiation program, newest first. Each row links the FDA's own label and letter. See the drug's page for its price, safety notices and trials: all negotiated drugs.
Changes, newest first
| Date | Drug | Class | Application | FDA documents |
|---|---|---|---|---|
| October 15, 2026 | Cosentyx | Labeling | BLA125504 | Label (PDF) posted October 20, 2026 |
| October 15, 2026 | Cosentyx | Efficacy | BLA761349 | Label (PDF) posted October 20, 2026FDA letter posted October 16, 2026 |
| October 14, 2026 | Enbrel | Labeling | BLA103795 | FDA letter posted October 16, 2026 |
| September 24, 2026 | Lenvima | Efficacy | NDA206947 | Label (PDF) posted September 28, 2026FDA letter posted September 28, 2026 |
| September 18, 2026 | Verzenio | Efficacy | NDA208716 | Label (PDF) posted September 22, 2026FDA letter posted September 22, 2026 |
| September 16, 2026 | Xeljanz | Labeling | NDA203214 | Label (PDF) posted September 22, 2026FDA letter posted September 21, 2026 |
| September 16, 2026 | Xeljanz | Labeling | NDA208246 | Label (PDF) posted September 22, 2026FDA letter posted September 21, 2026 |
| September 16, 2026 | Xeljanz | Labeling | NDA213082 | Label (PDF) posted September 22, 2026FDA letter posted September 21, 2026 |
| August 28, 2026 | Stelara | Labeling | BLA125261 | Label (PDF) posted September 1, 2026FDA letter posted September 1, 2026 |
| August 28, 2026 | Stelara | Efficacy | BLA761044 | Label (PDF) posted September 1, 2026FDA letter posted September 1, 2026 |
| August 27, 2026 | Ozempic | Labeling | NDA209637 | Label (PDF) posted August 28, 2026FDA letter posted August 28, 2026 |
| August 11, 2026 | Janumet | Labeling | NDA022044 | Label (PDF) posted August 18, 2026FDA letter posted August 14, 2026 |
| August 11, 2026 | Janumet | Labeling | NDA202270 | Label (PDF) posted August 18, 2026FDA letter posted August 14, 2026 |
| August 6, 2026 | Xolair | Labeling | BLA103976 | Label (PDF) posted August 11, 2026FDA letter posted August 10, 2026 |
| July 24, 2026 | Xtandi | Efficacy | NDA203415 | Label (PDF) posted July 27, 2026FDA letter posted July 28, 2026 |
| July 24, 2026 | Xtandi | Efficacy | NDA213674 | Label (PDF) posted July 27, 2026FDA letter posted July 28, 2026 |
| July 15, 2026 | Stelara | Labeling | BLA125261 | Label (PDF) posted July 29, 2026FDA letter posted July 16, 2026 |
| July 15, 2026 | Stelara | Labeling | BLA761044 | No document linked in the FDA file |
| July 13, 2026 | Verzenio | Efficacy | NDA208716 | Label (PDF) posted July 15, 2026FDA letter posted July 20, 2026 |
| July 1, 2026 | Kisqali | Efficacy | NDA209092 | Label (PDF) posted July 10, 2026FDA letter posted July 6, 2026 |
| June 30, 2026 | Xeljanz | Labeling | NDA203214 | Label (PDF) posted July 6, 2026FDA letter posted July 2, 2026 |
| June 30, 2026 | Xeljanz | Labeling | NDA208246 | Label (PDF) posted July 6, 2026FDA letter posted July 2, 2026 |
| June 30, 2026 | Xeljanz | Labeling | NDA213082 | Label (PDF) posted July 6, 2026FDA letter posted July 2, 2026 |
| June 29, 2026 | Erleada | Labeling | NDA210951 | Label (PDF) posted July 6, 2026FDA letter posted July 2, 2026 |
| June 24, 2026 | Eliquis | Labeling | NDA202155 | Label (PDF) posted June 29, 2026FDA letter posted June 26, 2026 |
| June 24, 2026 | Eliquis | Labeling | NDA220073 | Label (PDF) posted June 29, 2026FDA letter posted June 26, 2026 |
| June 24, 2026 | Ibrance | Efficacy | NDA207103 | Label (PDF) posted June 29, 2026FDA letter posted June 26, 2026 |
| June 24, 2026 | Ibrance | Efficacy | NDA212436 | Label (PDF) posted June 29, 2026FDA letter posted June 26, 2026 |
| June 18, 2026 | Ozempic | Labeling | NDA218316 | Label (PDF) posted June 23, 2026 |
| June 3, 2026 | Farxiga | Labeling | NDA202293 | Label (PDF) posted June 9, 2026FDA letter posted June 5, 2026 |
| June 1, 2026 | Ozempic | Labeling | NDA209637 | Label (PDF) posted June 10, 2026FDA letter posted June 2, 2026 |
| May 21, 2026 | Linzess | Efficacy | NDA202811 | Label (PDF) posted May 26, 2026FDA letter posted May 26, 2026 |
| May 5, 2026 | Ozempic | Labeling | NDA218316 | Label (PDF) posted May 12, 2026 |
| April 30, 2026 | Rexulti | Labeling | NDA205422 | Label (PDF) posted May 5, 2026FDA letter posted May 4, 2026 |
| April 27, 2026 | Pomalyst | REMS | NDA204026 | FDA letter posted May 1, 2026 |
| April 17, 2026 | Cosentyx | Efficacy | BLA125504 | Label (PDF) posted April 21, 2026FDA letter posted April 20, 2026 |
| April 17, 2026 | Cosentyx | Efficacy | BLA125504 | Label (PDF) posted April 21, 2026FDA letter posted April 20, 2026 |
| April 17, 2026 | Cosentyx | Labeling | BLA761349 | Label (PDF) posted August 26, 2026FDA letter posted April 20, 2026 |
| April 17, 2026 | Cosentyx | Labeling | BLA761349 | Label (PDF) posted April 21, 2026FDA letter posted April 20, 2026 |
| April 15, 2026 | Stelara | Labeling | BLA125261 | Label (PDF) posted April 20, 2026FDA letter posted April 16, 2026 |
| April 15, 2026 | Stelara | Efficacy | BLA761044 | Label (PDF) posted April 20, 2026FDA letter posted April 16, 2026 |
| March 24, 2026 | Xarelto | Labeling | NDA022406 | Label (PDF) posted March 26, 2026FDA letter posted March 27, 2026 |
| March 24, 2026 | Xarelto | Labeling | NDA215859 | Label (PDF) posted March 27, 2026FDA letter posted March 27, 2026 |
| March 19, 2026 | Ozempic | Efficacy | NDA215256 | Label (PDF) posted August 24, 2026FDA letter posted March 23, 2026 |
| March 19, 2026 | Ozempic | Labeling | NDA218316 | Label (PDF) posted March 24, 2026FDA letter posted March 23, 2026 |
| March 12, 2026 | Cosentyx | Efficacy | BLA125504 | Label (PDF) posted August 26, 2026FDA letter posted March 16, 2026 |
| March 12, 2026 | Cosentyx | Labeling | BLA761349 | Label (PDF) posted August 26, 2026FDA letter posted March 16, 2026 |
| March 12, 2026 | Trulicity | Labeling | BLA125469 | Label (PDF) posted March 18, 2026FDA letter posted March 16, 2026 |
| March 6, 2026 | Xeljanz | Efficacy | NDA203214 | Label (PDF) posted March 11, 2026FDA letter posted March 9, 2026 |
| March 6, 2026 | Xeljanz | Efficacy | NDA208246 | Label (PDF) posted March 11, 2026FDA letter posted March 9, 2026 |
| March 6, 2026 | Xeljanz | Efficacy | NDA213082 | Label (PDF) posted March 11, 2026FDA letter posted March 9, 2026 |
| March 5, 2026 | Erleada | Labeling | NDA210951 | Label (PDF) posted March 12, 2026FDA letter posted March 9, 2026 |
| February 25, 2026 | Entyvio | Labeling | BLA125476 | Label (PDF) posted March 2, 2026FDA letter posted February 27, 2026 |
| February 25, 2026 | Entyvio | Labeling | BLA761133 | Label (PDF) posted March 2, 2026FDA letter posted February 27, 2026 |
| February 25, 2026 | Ozempic | Labeling | NDA215256 | Label (PDF) posted March 2, 2026FDA letter posted February 27, 2026 |
| February 25, 2026 | Ozempic | Labeling | NDA218316 | Label (PDF) posted March 2, 2026FDA letter posted February 27, 2026 |
| February 19, 2026 | Calquence | Efficacy | NDA216387 | Label (PDF) posted February 24, 2026FDA letter posted February 23, 2026 |
| January 30, 2026 | Enbrel | Labeling | BLA103795 | Label (PDF) posted February 6, 2026FDA letter posted February 3, 2026 |
| January 30, 2026 | Ozempic | Labeling | NDA213051 | Label (PDF) posted July 31, 2026FDA letter posted February 3, 2026 |
| January 29, 2026 | Ozempic | Labeling | NDA215256 | Label (PDF) posted January 29, 2026FDA letter posted January 30, 2026 |
| January 29, 2026 | Ozempic | Labeling | NDA218316 | Label (PDF) posted February 5, 2026FDA letter posted January 30, 2026 |
| December 23, 2025 | Otezla | Labeling | NDA205437 | Label (PDF) posted December 30, 2025FDA letter posted December 31, 2025 |
| December 18, 2025 | Vraylar | Efficacy | NDA204370 | Label (PDF) posted December 22, 2025FDA letter posted December 19, 2025 |
| December 11, 2025 | Xtandi | Labeling | NDA203415 | Label (PDF) posted December 18, 2025FDA letter posted December 12, 2025 |
| December 11, 2025 | Xtandi | Labeling | NDA213674 | Label (PDF) posted December 18, 2025FDA letter posted December 12, 2025 |
| December 10, 2025 | Enbrel | Labeling | BLA103795 | FDA letter posted December 11, 2025 |
| November 21, 2025 | Ozempic | Efficacy | NDA215256 | Label (PDF) posted November 25, 2025FDA letter posted November 24, 2025 |
Questions
What counts as a label change here?
An FDA action on one of the drug's applications in Drugs@FDA, such as a labeling, efficacy or REMS supplement. Manufacturing (CMC) changes are left out because they do not change what the label tells a patient or prescriber. The class is the one FDA records for the action.
Does a row mean the drug label now says something new?
It means FDA recorded an action on that date and, where FDA linked them, the label and approval letter are one click away. This page does not summarise what changed; read the linked label for that.
Which drugs are covered?
The drugs in Medicare's negotiation program that have a page on OmniRx: 24 drugs have at least one change in the window and 39 drugs are covered.
For developers: recent changes as data
The change feed for the last 30 days (shortage rows, program status and NADAC prices) as one file, each event with a receipt.
Example file: https://omnirx.org/api/v1/changes/last-30-days.json
The licence page sets out what a data licence covers, and the API page documents these files.
Evaluation files with receipts; contract may change; not clinical advice.
Sources and terms. FDA Drugs@FDA data file, read November 7, 2026 (FDA data file); the FDA data-files page states no reuse terms. Dates are FDA action dates. Library edition 2026-11. Every figure is stored with its source and date in the OmniRx library: see where every figure comes from. Not medical, legal or financial advice. Licence the data.