🇺🇸 Myozyme in United States

FDA authorised Myozyme on 28 April 2006 · 1,524 US adverse-event reports

Marketing authorisations

FDA — authorised 28 April 2006

  • Application: BLA125141
  • Marketing authorisation holder: GENZYME
  • Local brand name: MYOZYME
  • Indication: INJECTABLE — IV (INFUSION)
  • Status: approved

Read official source →

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. Respiratory Failure — 242 reports (15.88%)
  2. Pyrexia — 218 reports (14.3%)
  3. Pneumonia — 199 reports (13.06%)
  4. Death — 177 reports (11.61%)
  5. Disease Progression — 154 reports (10.1%)
  6. Dyspnoea — 136 reports (8.92%)
  7. Oxygen Saturation Decreased — 105 reports (6.89%)
  8. Respiratory Distress — 104 reports (6.82%)
  9. Cardiac Failure — 101 reports (6.63%)
  10. Infusion Related Reaction — 88 reports (5.77%)

Source database →

Myozyme in other countries

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

Other Rare Disease approved in United States

Frequently asked questions

Is Myozyme approved in United States?

Yes. FDA authorised it on 28 April 2006; FDA has authorised it.

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

GENZYME holds the US marketing authorisation.