Osphena

Treats moderate to severe dyspareunia. NDA 203505, held by Duchesnay. Ospemifene.

As of Nov 14, 2026, NDA 203505 (Osphena), held by Duchesnay, was first approved by FDA on Feb 26, 2013, with 16 approved supplements and 0 published complete response letters.

First approved: Feb 26, 2013
Review: Standard
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

OSPHENA is indicated for: OSPHENA is an estrogen agonist/antagonist indicated for: The treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. The treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy, due to menopause. 1.1 The Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause. 1.2 The Treatment of Moderate to Severe Vaginal Dryness, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below


Jan 25, 2019	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 26, 2013	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Osphena60MG · tablet;oral	Ospemifene	RxReference drug

All 17 submissions, including labeling and manufacturing supplements


Feb 7, 2025	Supplement 18Labeling · Standard review	Approved	Label Letter
Feb 15, 2024	Supplement 22Labeling · Standard review	Approved	Label Letter
Jan 25, 2019	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 26, 2018	Supplement 14Labeling · Standard review	Approved	Label Letter
Mar 17, 2017	Supplement 12Manufacturing	Approved	None posted
Nov 3, 2016	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 24, 2015	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 24, 2015	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 24, 2015	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 23, 2015	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 20, 2015	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 25, 2015	Supplement 5Labeling · Standard review	Approved	Label Letter
May 2, 2014	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 8, 2014	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 27, 2013	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 13, 2013	Supplement 1Manufacturing · Standard review	Approved	None posted
Feb 26, 2013	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 203505
Drugs@FDA: Overview at FDA
Company: Duchesnay

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