Treats metastatic ovarian cancer after disease progression on or after initial or…. NDA 20671, held by Sandoz. Topotecan Hydrochloride.
As of Nov 13, 2026, NDA 20671 (Hycamtin), held by Sandoz, was first approved by FDA on May 28, 1996, with 16 approved supplements and 0 published complete response letters.
HYCAMTIN for injection is a topoisomerase inhibitor indicated for treatment of: Patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy, as a single agent Patients with small cell lung cancer (SCLC) platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy, as a single agent Patients with Stage IV-B, recurrent, or persistent cervical cancer which is not amenable to curative treatment, in combination with cisplatin 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 14, 2006 | Supplement 14Efficacy (new indication or use) · Priority review | Approved | |
| Feb 26, 2003 | Supplement 10Efficacy (new indication or use) · Priority review | Approved | |
| Nov 30, 1998 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| May 28, 1996 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| HycamtinEQ 4MG BASE/VIAL · injectable;injection | Topotecan Hydrochloride | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 8, 2019 | Supplement 24Labeling · Standard review | Approved | |
| Sep 5, 2018 | Supplement 23Labeling · Standard review | Approved | |
| Jun 2, 2015 | Supplement 21Labeling · Standard review | Approved | |
| Feb 28, 2014 | Supplement 20Labeling · Standard review | Approved | |
| Mar 26, 2010 | Supplement 16Labeling · Standard review | Approved | |
| Mar 26, 2010 | Supplement 17Labeling · Standard review | Approved | |
| Jun 14, 2006 | Supplement 14Efficacy (new indication or use) · Priority review | Approved | |
| May 9, 2003 | Supplement 12Labeling · Standard review | Approved | |
| Mar 11, 2003 | Supplement 11Labeling · Standard review | Approved | |
| Feb 26, 2003 | Supplement 10Efficacy (new indication or use) · Priority review | Approved | |
| Mar 6, 2002 | Supplement 9Labeling · Standard review | Approved | |
| Aug 3, 2001 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Feb 10, 2000 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Jan 18, 2000 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Nov 30, 1998 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Feb 4, 1998 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| May 28, 1996 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
