🇺🇸 BICALUTAMIDE in United States

FDA authorised BICALUTAMIDE on 4 October 1995 · 4,980 US adverse-event reports

Marketing authorisations

FDA — authorised 4 October 1995

  • Application: NDA020498
  • Marketing authorisation holder: ANI PHARMS
  • Status: supplemented

FDA — authorised 6 July 2009

  • Application: ANDA079089
  • Marketing authorisation holder: ADAPTIS
  • Status: supplemented

FDA — authorised 6 July 2009

  • Application: ANDA079110
  • Marketing authorisation holder: SUN PHARM
  • Status: approved

FDA — authorised 6 July 2009

  • Application: ANDA078917
  • Marketing authorisation holder: ACCORD HLTHCARE
  • 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. Fatigue — 838 reports (16.83%)
  2. Death — 608 reports (12.21%)
  3. Prostatic Specific Antigen Increased — 577 reports (11.59%)
  4. Prostate Cancer — 508 reports (10.2%)
  5. Hot Flush — 501 reports (10.06%)
  6. Asthenia — 483 reports (9.7%)
  7. Drug Ineffective — 445 reports (8.94%)
  8. Nausea — 356 reports (7.15%)
  9. Malignant Neoplasm Progression — 345 reports (6.93%)
  10. Dizziness — 319 reports (6.41%)

Source database →

BICALUTAMIDE in other countries

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

Frequently asked questions

Is BICALUTAMIDE approved in United States?

Yes. FDA authorised it on 4 October 1995; FDA authorised it on 6 July 2009; FDA authorised it on 6 July 2009.

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

ANI PHARMS holds the US marketing authorisation.