Quick answers
- What is Topotecan used for?
- The FDA-approved label (Hycamtin, Sandoz Inc, September 18, 2023) says: “HYCAMTIN ® capsules are indicated for the treatment of relapsed small cell lung cancer (SCLC) in patients with a prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy. HYCAMTIN capsules is a topoisomerase inhibitor indicated for treatment of patients with relapsed small cell lung cancer (SCLC).” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Topotecan have a boxed warning?
- Yes. The FDA label for Hycamtin has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Topotecan?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Topotecan been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Topotecan?
- 6 companies list prescription products of Topotecan in the FDA NDC Directory, including Sandoz Inc, Accord Healthcare Inc. and Fresenius Kabi USA, LLC.
What Topotecan is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
HYCAMTIN ® capsules are indicated for the treatment of relapsed small cell lung cancer (SCLC) in patients with a prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy. HYCAMTIN capsules is a topoisomerase inhibitor indicated for treatment of patients with relapsed small cell lung cancer (SCLC).
— FDA label: Hycamtin, Sandoz Inc, effective September 18, 2023. Read the full label on DailyMed →
The FDA has 7 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.
This label has a boxed warning. Read it on the full label →
7 of 7 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution · Capsule · Injection, solution, concentrate · Injection |
|---|---|
| Route | Intravenous · Oral |
| Prescription products | 8 in the FDA NDC Directory |
| Brand names | Hycamtin |
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.
- Sandoz Inc2 products
- Accord Healthcare Inc.2 products
- Fresenius Kabi USA, LLC1 product
- Novartis Pharmaceuticals Corporation1 product
- Actavis Pharma, Inc.1 product
- Hospira, 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 |
|---|---|---|---|
| NDA020671 HYCAMTIN | Sandoz | May 28, 1996 | 16, latest October 8, 2019 2019: Labeling · 2018: Labeling · 2015: Labeling |
| NDA020981 HYCAMTIN | Sandoz | October 11, 2007 | 5, latest September 5, 2018 2018: Labeling · 2014: Labeling · 2011: Labeling |
| NDA200582 TOPOTECAN HYDROCHLORIDE | Hospira Inc | February 2, 2011 | 3, latest December 16, 2019 2019: Labeling · 2016: Labeling · 2014: Labeling |
Generic approvals (4)
- ANDA091089Fresenius Kabi USA · November 29, 2010
- ANDA090620Actavis Totowa · December 2, 2010
- ANDA202351Accord Hlthcare · June 26, 2013
- ANDA204406Accord Hlthcare · July 6, 2017
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Hycamtin, Sandoz Inc, effective September 18, 2023; 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 →