Application Nr Approved Date Route Status External Links
ANDA077135 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 Tablets, Usp Is A Nucleoside Analogue Dna Polymerase Inhibitor Indicated For: Adult Patients ( 1.1) Cold Sores (herpes Labialis) Genital Herpes O Treatment In Immunocompetent Patients (initial Or Recurrent Episode) O Suppression In Immunocompetent Or Hiv-Infected Patients O Reduction Of Transmission Herpes Zoster Pediatric Patients ( 1.2) Cold Sores (herpes Labialis) Chickenpox Limitations Of Use ( 1.3) The Efficacy And Safety Of Valacyclovir Tablets, Usp 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 Tablets, Usp Are Indicated For Treatment Of Cold Sores (herpes Labialis). The Efficacy Of Valacyclovir Tablets, Usp 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 Tablets, Usp Are Indicated For Treatment Of The Initial Episode Of Genital Herpes In Immunocompetent Adults. The Efficacy Of Treatment With Valacyclovir Tablets, Usp When Initiated More Than 72 Hours After The Onset Of Signs And Symptoms Has Not Been Established. Recurrent Episodes: Valacyclovir Tablets, Usp Are Indicated For Treatment Of Recurrent Episodes Of Genital Herpes In Immunocompetent Adults. The Efficacy Of Treatment With Valacyclovir Tablets, Usp When Initiated More Than 24 Hours After The Onset Of Signs And Symptoms Has Not Been Established. Suppressive Therapy: Valacyclovir Tablets, Usp 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 Tablets, Usp 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 Tablets, Usp Are Indicated For The Reduction Of Transmission Of Genital Herpes In Immunocompetent Adults. The Efficacy Of Valacyclovir Tablets, Usp For The Reduction Of Transmission Of Genital Herpes Beyond 8 Months In Discordant Couples Has Not Been Established. The Efficacy Of Valacyclovir Tablets, Usp 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 Tablets, Usp Are Indicated For The Treatment Of Herpes Zoster (shingles) In Immunocompetent Adults. The Efficacy Of Valacyclovir Tablets, Usp When Initiated More Than 72 Hours After The Onset Of Rash And The Efficacy And Safety Of Valacyclovir Tablets, Usp For Treatment Of Disseminated Herpes Zoster Have Not Been Established. 1.2 Pediatric Patients Cold Sores (herpes Labialis): Valacyclovir Tablets, Usp Are Indicated For The Treatment Of Cold Sores (herpes Labialis) In Pediatric Patients ≥12 Years Of Age. The Efficacy Of Valacyclovir Tablets, Usp Initiated After The Development Of Clinical Signs Of A Cold Sore (e.g., Papule, Vesicle, Or Ulcer) Has Not Been Established. Chickenpox: Valacyclovir Tablets, Usp Are Indicated For The Treatment Of Chickenpox In Immunocompetent Pediatric Patients 2 To <18 Years Of Age. Based On Efficacy Data From Clinical Studies With Oral Acyclovir, Treatment With Valacyclovir Tablets, Usp Should Be Initiated Within 24 Hours After The Onset Of Rash [see Clinical Studies (14.4)] . 1.3 Limitations Of Use The Efficacy And Safety Of Valacyclovir Tablets, Usp 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/mm 3. Patients <12 Years Of Age With Cold Sores (herpes Labialis). Patients <2 Years Of Age Or ≥18 Years Of Age With Chickenpox. 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.

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
2. Hydrogenated Castor Oil HYDROGENATED CASTOR OIL Molecular
3. Hypromelloses HYPROMELLOSES 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.

Active Ingredients ( 1 Total)

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

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