Treats metastatic breast cancer in postmenopausal women with estrogen-receptor positive…. NDA 20497, held by Kyowa Kirin. Toremifene Citrate.
As of Nov 13, 2026, NDA 20497 (Fareston), held by Kyowa Kirin, was first approved by FDA on May 29, 1997, with 6 approved supplements and 0 published complete response letters.
FARESTON is an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 29, 1997 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| FarestonEQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Toremifene Citrate | DiscontinuedReference drug |
| Dec 13, 2024 | Supplement 18Labeling · Standard review | Approved | |
| May 12, 2017 | Supplement 9Labeling · Standard review | Approved | |
| Mar 21, 2011 | Supplement 6Labeling · Standard review | Approved | |
| Jul 10, 2000 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Dec 1, 1998 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Nov 20, 1997 | Supplement 1Labeling · Standard review | Approved | None posted |
| May 29, 1997 | Original applicationNew molecular entity · Standard review | Approved | None posted |
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
