Jalyn

Treats symptomatic benign prostatic hyperplasia (BPH). NDA 22460, held by Waylis Therap. Dutasteride; Tamsulosin Hydrochloride.

As of Nov 15, 2026, NDA 22460 (Jalyn), held by Waylis Therap, was first approved by FDA on Jun 14, 2010, with 9 approved supplements and 0 published complete response letters.

First approved: Jun 14, 2010
Review: Standard
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

JALYN is a combination of dutasteride, a 5-alpha-reductase inhibitor, and tamsulosin, an alpha-adrenergic antagonist, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. Limitations of Use: Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer. 1.1 Benign Prostatic Hyperplasia (BPH) Treatment JALYN (dutasteride and tamsulosin hydrochloride) capsules are indicated for the treatment of symptomatic BPH in men with an enlarged prostate. 1.2 Limitations of Use Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Jun 14, 2010	Original applicationNew combination · Standard review	Approved	Review Summary Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Jalyn0.5MG;0.4MG · capsule;oral	Dutasteride; Tamsulosin Hydrochloride	RxReference drug

All 10 submissions, including labeling and manufacturing supplements


Dec 29, 2020	Supplement 11Labeling · Standard review	Approved	Label Letter
Nov 1, 2017	Supplement 8Labeling · Standard review	Approved	Label
Nov 1, 2017	Supplement 7Labeling · Standard review	Approved	Label
Jun 13, 2016	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 25, 2013	Supplement 5Labeling · Standard review	Approved	Letter Label
Apr 25, 2013	Supplement 4Labeling	Approved	Letter Label
Apr 25, 2013	Supplement 3Labeling	Approved	Letter Label
Jun 27, 2012	Supplement 2Labeling	Approved	Letter Label
Jun 9, 2011	Supplement 1Labeling	Approved	Letter Label
Jun 14, 2010	Original applicationNew combination · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22460
Drugs@FDA: Overview at FDA
Company: Waylis Therapeutics

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