🇺🇸 Intrathecal in United States

FDA authorised Intrathecal on 11 September 2019 · 3,436 US adverse-event reports

Marketing authorisations

FDA — authorised 11 September 2019

  • Application: ANDA210048
  • Marketing authorisation holder: MAIA PHARMS INC
  • 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. Muscle Spasticity — 606 reports (17.64%)
  2. Drug Withdrawal Syndrome — 585 reports (17.03%)
  3. Pain — 561 reports (16.33%)
  4. Muscle Spasms — 331 reports (9.63%)
  5. No Therapeutic Response — 315 reports (9.17%)
  6. Overdose — 294 reports (8.56%)
  7. Therapeutic Response Decreased — 240 reports (6.98%)
  8. Malaise — 169 reports (4.92%)
  9. Fall — 168 reports (4.89%)
  10. Nausea — 167 reports (4.86%)

Source database →

Intrathecal in other countries

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

Other Other approved in United States

Frequently asked questions

Is Intrathecal approved in United States?

Yes. FDA authorised it on 11 September 2019; FDA has authorised it.

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

MAIA PHARMS INC holds the US marketing authorisation.