Evista

Prevents osteoporosis in postmenopausal women. NDA 20815, held by Lilly. Raloxifene Hydrochloride.

As of Nov 14, 2026, NDA 20815 (Evista), held by Lilly, was first approved by FDA on Dec 9, 1997, with 17 approved supplements and 0 published complete response letters.

First approved: Dec 9, 1997
Review: Priority
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

EVISTA is an estrogen agonist/antagonist indicated for: Treatment and prevention of osteoporosis in postmenopausal women. Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. Reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer. Important Limitations: EVISTA is not indicated for the treatment of invasive breast cancer, reduction of the risk of recurrence of breast cancer, or reduction of risk of noninvasive breast cancer. 1.1 Treatment and Prevention of Osteoporosis in Postmenopausal Women EVISTA is indicated for the treatment and prevention of osteoporosis in postmenopausal women. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below


Sep 30, 1999	Supplement 3Efficacy (new indication or use) · Priority review	Approved	Label Letter Review
Nov 24, 1998	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Review
Dec 9, 1997	Original applicationNew molecular entity · Priority review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Evista60MG · tablet;oral	Raloxifene Hydrochloride	RxReference drug

All 18 submissions, including labeling and manufacturing supplements


Jun 27, 2018	Supplement 34Labeling · Standard review	Approved	Letter Label
Jan 25, 2016	Supplement 33Manufacturing · Priority review	Approved	None posted
Jan 11, 2016	Supplement 32Manufacturing · Priority review	Approved	None posted
Sep 13, 2007	Supplement 25Labeling · Standard review	Approved	Letter
Jul 17, 2007	Supplement 18Labeling · Standard review	Approved	Letter Label
Dec 24, 2002	Supplement 12Manufacturing · Priority review	Approved	None posted
Jun 13, 2002	Supplement 10Labeling · Standard review	Approved	None posted
May 7, 2002	Supplement 11Manufacturing · Priority review	Approved	None posted
Jan 17, 2002	Supplement 9Manufacturing · Priority review	Approved	None posted
Jul 2, 2001	Supplement 8Manufacturing · Priority review	Approved	None posted
Dec 13, 2000	Supplement 7Labeling · Standard review	Approved	None posted
Jun 27, 2000	Supplement 6Labeling · Standard review	Approved	None posted
Jun 23, 2000	Supplement 5Manufacturing · Priority review	Approved	None posted
May 9, 2000	Supplement 4Manufacturing · Priority review	Approved	None posted
Sep 30, 1999	Supplement 3Efficacy (new indication or use) · Priority review	Approved	Label Letter Review
Nov 24, 1998	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Review
Oct 26, 1998	Supplement 1Manufacturing · Priority review	Approved	None posted
Dec 9, 1997	Original applicationNew molecular entity · Priority review	Approved	Review

Identifiers

Application: NDA 20815
Drugs@FDA: Overview at FDA
Company: Lilly

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