Valtrex

Reduces transmission Herpes Zoster Pediatric Patients Cold Sores (Herpes Labialis)…. NDA 20487, held by Glaxosmithkline. Valacyclovir Hydrochloride.

As of Nov 14, 2026, NDA 20487 (Valtrex), held by Glaxosmithkline, was first approved by FDA on Jun 23, 1995, with 11 approved supplements and 0 published complete response letters.

First approved: Jun 23, 1995
Review: Standard
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

VALTREX is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients Cold Sores (Herpes Labialis) Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-1−infected patients Reduction of transmission Herpes Zoster Pediatric Patients Cold Sores (Herpes Labialis) Chickenpox Limitations of Use The efficacy and safety of VALTREX have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1−infected patients. 1.1 Adult Patients Cold Sores (Herpes Labialis) VALTREX is indicated for treatment of cold sores (herpes labialis).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below


Sep 2, 2008	Supplement 14Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jun 23, 1995	Original applicationNew active ingredient · Standard review	Approved	Pediatric Medical Review Pediatric Clinical Pharmacology Review Pediatric Clinical Pharmacology Review Pediatric Amendment 1

Products

2 strengths and forms


ValtrexEQ 500MG BASE · tablet;oral	Valacyclovir Hydrochloride	RxReference drug
ValtrexEQ 1GM BASE · tablet;oral	Valacyclovir Hydrochloride	RxReference drug

All 12 submissions, including labeling and manufacturing supplements


Nov 12, 2025	Supplement 23Labeling · Standard review	Approved	Label Letter
Jun 14, 2021	Supplement 22Labeling · Standard review	Approved	Letter Label
Dec 10, 2019	Supplement 20Labeling · Standard review	Approved	Letter Label
Apr 19, 2010	Supplement 16Labeling	Approved	Letter Label
Sep 2, 2008	Supplement 14Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 11, 2007	Supplement 13Labeling · Standard review	Approved	Letter Label
Nov 23, 2005	Supplement 7Labeling · Standard review	Approved	Label Letter
Dec 3, 2004	Supplement 5Labeling · Standard review	Approved	Review Letter Label
Jan 13, 1997	Supplement 4Labeling · Standard review	Approved	Review
Aug 9, 1996	Supplement 3Manufacturing · Standard review	Approved	Review
Sep 8, 1995	Supplement 2Manufacturing · Standard review	Approved	Review
Jun 23, 1995	Original applicationNew active ingredient · Standard review	Approved	Pediatric Medical Review Pediatric Clinical Pharmacology Review Pediatric Clinical Pharmacology Review Pediatric Amendment 1

Identifiers

Application: NDA 20487
Drugs@FDA: Overview at FDA
Company: GlaxoSmithKline LLC

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