Quick answers
- What is Gemcitabine used for?
- The FDA-approved label (Avgemsi, Avyxa Pharma, LLC, July 27, 2026) says: “AVGEMSI is a nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Gemcitabine have a boxed warning?
- No. None of the 17 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Gemcitabine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Gemcitabine been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started June 10, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Gemcitabine?
- 12 companies list prescription products of Gemcitabine in the FDA NDC Directory, including Hospira, Inc., Fresenius Kabi USA, LLC and Meitheal Pharmaceuticals Inc..
What Gemcitabine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
AVGEMSI is a nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. …
— FDA label: Avgemsi, Avyxa Pharma, LLC, effective July 27, 2026. Read the full label on DailyMed →
The FDA has 17 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 17 FDA labels for this medicine have a boxed warning.
Forms and how it is given
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Hospira, Inc.9 products
- Fresenius Kabi USA, LLC5 products
- Meitheal Pharmaceuticals Inc.4 products
- Hikma Pharmaceuticals USA Inc.3 products
- Sagent Pharmaceuticals3 products
- Mylan Institutional LLC3 products
- NorthStar Rx LLC2 products
- Gland Pharma Limited2 products
- Avyxa Pharma, LLC2 products
- Dr. Reddy's Laboratories Limited2 products
- Teyro Labs Private Limited2 products
- Janssen Biotech, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA200795 GEMCITABINE HYDROCHLORIDE | Hospira Inc | August 4, 2011 | 9, latest May 31, 2024 2024: Labeling · 2019: Labeling · 2018: Labeling |
| NDA219683 INLEXZO | Janssen Biotech | September 9, 2025 | — |
| NDA219920 AVGEMSI | Avyxa Holdings | June 27, 2025 | 1, latest June 27, 2025 2025: Type 5 - New Formulation or New Manufacturer |
Generic approvals (11)
- ANDA079183Hospira Inc · November 15, 2010
- ANDA090799Fresenius Kabi USA · May 16, 2011
- ANDA078339Hospira · July 25, 2011
- ANDA078759Teyro Labs · July 25, 2011
- ANDA091365DR Reddys Labs Ltd · July 25, 2011
- ANDA202485Jiangsu Hansoh Pharm · May 7, 2013
- ANDA204520Gland · January 5, 2016
- ANDA205242Mylan Labs Ltd · December 6, 2017
- ANDA209077Sagent Pharms Inc · July 20, 2018
- ANDA212129Meitheal · December 11, 2020
- ANDA213175Hikma · March 7, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
June 10, 2026 · Class II · Ongoing · D-0714-2026
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany; Distributed by: Hik — McKesson
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Avgemsi, Avyxa Pharma, LLC, effective July 27, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →