FDA — authorised 11 December 2007
- Application: NDA020487
- Marketing authorisation holder: GLAXOSMITHKLINE
- Indication: Labeling
- Status: approved
🇺🇸 VALACYCLOVIR in United States
FDA authorised VALACYCLOVIR on 11 December 2007 · 19,409 US adverse-event reports
Marketing authorisations
FDA — authorised 24 May 2010
- Application: ANDA079012
- Marketing authorisation holder: RISING
- Status: supplemented
FDA — authorised 24 May 2010
- Application: ANDA090682
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 20 July 2010
- Application: ANDA076588
- Marketing authorisation holder: SUN PHARM INDS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 3 April 2012
- Application: ANDA201506
- Marketing authorisation holder: JUBILANT GENERICS
- Status: supplemented
FDA — authorised 8 April 2015
- Application: ANDA203047
- Marketing authorisation holder: HETERO LABS LTD V
- Status: approved
FDA — authorised 18 March 2020
- Application: ANDA209553
- Marketing authorisation holder: YILING
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 19,409
Most-reported reactions
- Off Label Use — 2,675 reports (13.78%)
- Fatigue — 2,567 reports (13.23%)
- Diarrhoea — 2,323 reports (11.97%)
- Nausea — 2,044 reports (10.53%)
- Drug Ineffective — 2,036 reports (10.49%)
- Pyrexia — 1,614 reports (8.32%)
- Febrile Neutropenia — 1,613 reports (8.31%)
- Pneumonia — 1,582 reports (8.15%)
- Headache — 1,511 reports (7.79%)
- Pain — 1,444 reports (7.44%)
VALACYCLOVIR in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is VALACYCLOVIR approved in United States?
Yes. FDA authorised it on 11 December 2007; FDA authorised it on 24 May 2010; FDA authorised it on 24 May 2010.
Who is the marketing authorisation holder for VALACYCLOVIR in United States?
GLAXOSMITHKLINE holds the US marketing authorisation.