🇺🇸 Rocklatan in United States

FDA authorised Rocklatan on 12 March 2019 · 720 US adverse-event reports

Marketing authorisations

FDA — authorised 12 March 2019

  • Application: NDA208259
  • Marketing authorisation holder: ALCON LABS INC
  • Status: supplemented

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. Ocular Hyperaemia — 112 reports (15.56%)
  2. Eye Irritation — 103 reports (14.31%)
  3. Conjunctival Hyperaemia — 93 reports (12.92%)
  4. Vision Blurred — 90 reports (12.5%)
  5. Eye Pain — 76 reports (10.56%)
  6. Lacrimation Increased — 72 reports (10%)
  7. Eye Pruritus — 58 reports (8.06%)
  8. Product Dose Omission Issue — 48 reports (6.67%)
  9. Death — 34 reports (4.72%)
  10. Intraocular Pressure Increased — 34 reports (4.72%)

Source database →

Rocklatan 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 Rocklatan approved in United States?

Yes. FDA authorised it on 12 March 2019; FDA has authorised it.

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

ALCON LABS INC holds the US marketing authorisation.