Application Nr Approved Date Route Status External Links
ANDA090682 2010-05-24 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Valacyclovir Hydrochloride Is A Nucleoside Analogue Dna Polymerase Inhibitor Indicated For: Adult Patients (1.1) Cold Sores (herpes Labialis) Genital Herpes Treatment In Immunocompetent Patients (initial Or Recurrent Episode) Suppression In Immunocompetent Or Hiv-Infected Patients Reduction Of Transmission Herpes Zoster Pediatric Patients (1.2) Cold Sores (herpes Labialis) Limitations Of Use (1.3) The Efficacy And Safety Of Valacyclovir Hydrochloride Tablets Have Not Been Established In Immunocompromised Patients Other Than For The Suppression Of Genital Herpes In Hiv-Infected Patients. 1.1 Adult Patients Cold Sores (herpes Labialis): Valacyclovir Hydrochloride Tablets Are Indicated For Treatment Of Cold Sores (herpes Labialis). The Efficacy Of Valacyclovir Hydrochloride Tablets Initiated After The Development Of Clinical Signs Of A Cold Sore (e.g., Papule, Vesicle, Or Ulcer) Has Not Been Established. Genital Herpes: Initial Episode: Valacyclovir Hydrochloride Tablets Are Indicated For Treatment Of The Initial Episode Of Genital Herpes In Immunocompetent Adults. The Efficacy Of Treatment With Valacyclovir Hydrochloride Tablets When Initiated More Than 72 Hours After The Onset Of Signs And Symptoms Has Not Been Established. Recurrent Episodes: Valacyclovir Hydrochloride Tablets Are Indicated For Treatment Of Recurrent Episodes Of Genital Herpes In Immunocompetent Adults. The Efficacy Of Treatment With Valacyclovir Hydrochloride Tablets When Initiated More Than 24 Hours After The Onset Of Signs And Symptoms Has Not Been Established. Suppressive Therapy: Valacyclovir Hydrochloride Tablets Are Indicated For Chronic Suppressive Therapy Of Recurrent Episodes Of Genital Herpes In Immunocompetent And In Hiv-Infected Adults. The Efficacy And Safety Of Valacyclovir Hydrochloride Tablets For The Suppression Of Genital Herpes Beyond 1 Year In Immunocompetent Patients And Beyond 6 Months In Hiv-Infected Patients Have Not Been Established. Reduction Of Transmission: Valacyclovir Hydrochloride Tablets Are Indicated For The Reduction Of Transmission Of Genital Herpes In Immunocompetent Adults. The Efficacy Of Valacyclovir Hydrochloride Tablets For The Reduction Of Transmission Of Genital Herpes Beyond 8 Months In Discordant Couples Has Not Been Established. The Efficacy Of Valacyclovir Hydrochloride Tablets For The Reduction Of Transmission Of Genital Herpes In Individuals With Multiple Partners And Non-Heterosexual Couples Has Not Been Established. Safer Sex Practices Should Be Used With Suppressive Therapy (see Current Centers For Disease Control And Prevention [cdc] Sexually Transmitted Diseases Treatment Guidelines ). Herpes Zoster: Valacyclovir Hydrochloride Tablets Are Indicated For The Treatment Of Herpes Zoster (shingles) In Immunocompetent Adults. The Efficacy Of Valacyclovir Hydrochloride Tablets When Initiated More Than 72 Hours After The Onset Of Rash And The Efficacy And Safety Of Valacyclovir Hydrochloride Tablets For Treatment Of Disseminated Herpes Zoster Have Not Been Established. 1.2 Pediatric Patients Cold Sores (herpes Labialis): Valacyclovir Hydrochloride Tablets Are Indicated For The Treatment Of Cold Sores (herpes Labialis) In Pediatric Patients ≥12 Years Of Age. The Efficacy Of Valacyclovir Hydrochloride Tablets Initiated After The Development Of Clinical Signs Of A Cold Sore (e.g., Papule, Vesicle, Or Ulcer) Has Not Been Established. Labeling Describing Use Of Valacyclovir Hydrochloride Tablets In Pediatric Patients With Chickenpox (ages 2 To ≤ 18 Years) Is Approved For Glaxosmithkline’s Valtrex ® Caplets. However, Due To Glaxosmithkline’s Marketing Exclusivity Rights, A Description Of That Pediatric Use Is Not Approved For This Valacyclovir Hydrochloride Tablet Product. 1.3 Limitations Of Use The Efficacy And Safety Of Valacyclovir Hydrochloride Tablets Have Not Been Established In: Immunocompromised Patients Other Than For The Suppression Of Genital Herpes In Hiv-Infected Patients With A Cd4+ Cell Count ≥100 Cells/mm3. Patients <12 Years Of Age With Cold Sores (herpes Labialis). Patients <18 Years Of Age With Genital Herpes. Patients <18 Years Of Age With Herpes Zoster. Neonates And Infants As Suppressive Therapy Following Neonatal Herpes Simplex Virus (hsv) Infection. Labeling Describing Use Of Valacyclovir Hydrochloride Tablets In Pediatric Patients With Chickenpox (ages Of 2 To ≤ 18 Years) Is Approved For Glaxosmithkline’s Valtrex® Caplets. However, Due To Glaxosmithkline’s Marketing Exclusivity Rights, A Description Of That Pediatric Use Is Not Approved For This Valacyclovir Hydrochloride Tablet Product.

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
3. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
4. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
5. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
6. Povidones POVIDONES Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Valacyclovir Hydrochloride VALACYCLOVIR HYDROCHLORIDE ZINC1530713

Comments