🇺🇸 PrEP in United States

FDA authorised PrEP on 5 August 2010 · 5,140 US adverse-event reports

Marketing authorisations

FDA — authorised 5 August 2010

  • Application: NDA022372
  • Marketing authorisation holder: AZURITY
  • Status: supplemented

FDA — authorised 20 December 2013

  • Application: ANDA204756
  • Marketing authorisation holder: AVET LIFESCIENCES
  • Local brand name: METOCLOPRAMIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 19 March 2024

  • Application: ANDA206431
  • Marketing authorisation holder: TARO
  • Status: approved

FDA

  • 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.

Most-reported reactions

  1. Vomiting — 1,632 reports (31.75%)
  2. Nausea — 1,161 reports (22.59%)
  3. Abdominal Distension — 397 reports (7.72%)
  4. Abdominal Pain — 396 reports (7.7%)
  5. Headache — 393 reports (7.65%)
  6. Drug Ineffective — 384 reports (7.47%)
  7. Dizziness — 245 reports (4.77%)
  8. Abdominal Pain Upper — 198 reports (3.85%)
  9. Wrong Technique In Product Usage Process — 169 reports (3.29%)
  10. Tremor — 165 reports (3.21%)

Source database →

PrEP in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is PrEP approved in United States?

Yes. FDA authorised it on 5 August 2010; FDA authorised it on 20 December 2013; FDA authorised it on 19 March 2024.

Who is the marketing authorisation holder for PrEP in United States?

AZURITY holds the US marketing authorisation.