🇺🇸 Intrarosa in United States

FDA authorised Intrarosa on 16 November 2016 · 1,334 US adverse-event reports

Marketing authorisations

FDA — authorised 16 November 2016

  • Application: NDA208470
  • Marketing authorisation holder: MILLICENT
  • 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. Off Label Use — 686 reports (51.42%)
  2. Application Site Discharge — 112 reports (8.4%)
  3. Drug Ineffective — 107 reports (8.02%)
  4. Vaginal Discharge — 84 reports (6.3%)
  5. Vulvovaginal Burning Sensation — 77 reports (5.77%)
  6. Product Dose Omission Issue — 67 reports (5.02%)
  7. Therapeutic Response Unexpected — 52 reports (3.9%)
  8. Alopecia — 51 reports (3.82%)
  9. Product Administration Error — 50 reports (3.75%)
  10. Headache — 48 reports (3.6%)

Source database →

Intrarosa in other countries

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

Other Immunology approved in United States

Frequently asked questions

Is Intrarosa approved in United States?

Yes. FDA authorised it on 16 November 2016; FDA has authorised it.

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

MILLICENT holds the US marketing authorisation.