Herpes Simplex Labialis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2026-04-14FDA Approved: ABREVA — Supplemental Application (Haleon US Holdings LLC)
FDA approved a supplemental application for ABREVA (docosanol) submitted by Haleon US Holdings LLC. ABREVA is an OTC topical treatment for h…
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FDA approval · 2024-03-01FDA Approved: AMAZON BASICS DOCOSANOL — Original Application (Amazon.com Services LLC)
FDA approved the original application for AMAZON BASICS DOCOSANOL (docosanol) topical cream.
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FDA approval · 2023-08-28FDA Approved: DOCOSANOL — Supplemental Application (Care One (Retail Business Services, LLC.))
The FDA approved a supplemental application for Docosanol (DOCOSANOL) submitted by Care One (Retail Business Services, LLC.), updating the p…
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FDA approval · 2023-08-07FDA Approved: PENCICLOVIR — Original Application (Torrent Pharmaceuticals Limited)
FDA approves Torrent Pharmaceuticals' generic penciclovir for topical treatment of herpes simplex labialis (cold sores) as an original ANDA.
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FDA approval · 2022-05-03FDA Approved: DOCOSANOL — Original Application (Alembic Pharmaceuticals Limited)
FDA approved the Original Application for docosanol from Alembic Pharmaceuticals Limited.
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FDA approval · 2020-03-18FDA Approved: VALACYCLOVIR — Original Application (Westminster Pharmaceuticals, LLC)
FDA approved Westminster Pharmaceuticals' original ANDA for valacyclovir (valacyclovir hydrochloride), a generic antiviral used to treat her…
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CLINICAL_TRIALS trial_result · 2019-05-30Clinical Trial Update: Safety, Tolerability and Therapeutic Efficacy of Topical ZEP-3 Ointment (1.0%) for the Treatment of Cold Sores [Phase 2]
Phase 2 trial update on topical ZEP-3 1.0% ointment for herpes labialis shows safety, tolerability, and therapeutic efficacy.
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CLINICAL_TRIALS trial_result · 2018-04-10Clinical Trial Update: Effectiveness and Clinical Mechanism of Huanglian-Jiedu Decoction in Patients With Intense-exuberant Stomach Fire Syndrome [Phase 1, Phase 2]
A clinical trial update on Huanglian-Jiedu Decoction in Phase 1/Phase 2 evaluating its use for Intense-exuberant Stomach Fire Syndrome and r…
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CLINICAL_TRIALS trial_result · 2017-10-12Clinical Trial Update: Immune Response to the Consumption of Lactobacillus GG and FOS in Patients With Recurrent Herpes Labialis [NA]
A clinical trial evaluating immune responses to Lactobacillus GG and Fructooligosaccharides in patients with recurrent herpes simplex labial…
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FDA label_change · 2017-01-10FDA Approved: ABREVA — Supplemental Application (Haleon US Holdings LLC)
FDA approved a supplemental application for ABREVA (docosanol) submitted by Haleon US Holdings LLC.
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FDA approval · 2015-02-09FDA Approved: DENAVIR — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for Denavir (penciclovir) submitted by Mylan Pharmaceuticals Inc. This action updates the regula…
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FDA approval · 2015-01-30FDA Approved: ABREVA — Supplemental Application (Haleon US Holdings LLC)
The FDA approved a supplemental application for ABREVA (docosanol) submitted by Haleon US Holdings LLC.
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CLINICAL_TRIALS trial_result · 2014-06-05Clinical Trial Update: Clinical Assessment of the Effectiveness and Safety of Herpes Patch SOS in the Treatment of Herpes Simplex Labialis in Comparison to a Competitor's Product. [NA]
Completed clinical trial evaluating the effectiveness and safety of Herpes Patch SOS for treating herpes simplex labialis in comparison with…
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CLINICAL_TRIALS trial_result · 2014-01-08Clinical Trial Update: Zinc for the Treatment of Herpes Simplex Labialis (HSL) [Phase 3]
This entry reports the completion and results posting of a Phase 3 trial evaluating zinc for the treatment of herpes simplex labialis (cold …
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FDA approval · 2013-09-11FDA Approved: DENAVIR — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for Denavir (penciclovir) filed by Mylan Pharmaceuticals, updating the regulatory status of the …
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CLINICAL_TRIALS trial_result · 2013-05-23Clinical Trial Update: A Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis [Phase 3]
A Phase 3 multicenter study evaluating NB-001 for recurrent herpes labialis has completed.
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CLINICAL_TRIALS trial_result · 2013-03-04Clinical Trial Update: Non-inferiority Comparison of Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis [Phase 3]
Phase 3 non-inferiority trial comparing penciclovir 10 mg/g cream to acyclovir 50 mg/g cream for recurrent herpes simplex labialis has compl…
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FDA approval · 2010-05-24FDA Approved: VALACYCLOVIR HYDROCHLORIDE — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved the original application for valacyclovir hydrochloride (valacyclovir) by Mylan Pharmaceuticals Inc., a generic antiviral. The …
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CLINICAL_TRIALS trial_result · 2008-08-18Clinical Trial Update: Safety Study of ME-609 for Treatment of Herpes Simplex Labialis in Adolescents [Phase 3]
This clinical trial update reports the completion of a Phase 3 safety study of ME-609 for the treatment of herpes simplex labialis in adoles…
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FDA approval · 2008-02-08FDA Approved: ABREVA — Supplemental Application (Haleon US Holdings LLC)
FDA approved a supplemental application for ABREVA (docosanol) from Haleon US Holdings LLC.
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FDA approval · 2007-12-11FDA Approved: VALTREX — Supplemental Application (GlaxoSmithKline LLC)
The FDA approved a supplemental application for Valtrex (valacyclovir hydrochloride) submitted by GlaxoSmithKline LLC, authorizing changes t…