🇺🇸 Duvalizumab in United States

5 US adverse-event reports

Marketing authorisations

FDA

  • Application: ANDA208927
  • Marketing authorisation holder: BIOCON LTD
  • Local brand name: PEMETREXED
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: NDA208297
  • Marketing authorisation holder: DR REDDYS LABS INC
  • Local brand name: PEMETREXED FOR INJECTION
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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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. Drug Ineffective — 1 report (20%)
  2. Gamma-Glutamyltransferase Increased — 1 report (20%)
  3. Hypersensitivity — 1 report (20%)
  4. Urinary Retention — 1 report (20%)
  5. Vomiting — 1 report (20%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Duvalizumab approved in United States?

Yes. FDA has authorised it; FDA has authorised it.

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

BIOCON LTD holds the US marketing authorisation.