Treats relapsed small cell lung cancer (SCLC). NDA 20981, held by Sandoz. Topotecan Hydrochloride.
As of Nov 13, 2026, NDA 20981 (Hycamtin), held by Sandoz, was first approved by FDA on Oct 11, 2007, with 5 approved supplements and 0 published complete response letters.
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).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 11, 2007 | Original applicationNew dosage form · Priority review | Approved |
| HycamtinEQ 0.25MG BASE · capsule;oral | Topotecan Hydrochloride | RxReference drug |
| HycamtinEQ 1MG BASE · capsule;oral | Topotecan Hydrochloride | RxReference drug |
| Sep 5, 2018 | Supplement 8Labeling · Standard review | Approved | |
| Jun 18, 2014 | Supplement 6Labeling · Standard review | Approved | |
| Oct 7, 2011 | Supplement 5Labeling | Approved | |
| Jun 30, 2010 | Supplement 2Labeling · Standard review | Approved | |
| Sep 5, 2008 | Supplement 1Manufacturing | Approved | None posted |
| Oct 11, 2007 | Original applicationNew dosage form · 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
