🇺🇸 megestrol in United States

FDA authorised megestrol on 30 November 1995 · 5,151 US adverse-event reports

Marketing authorisations

FDA — authorised 30 November 1995

  • Application: ANDA074621
  • Marketing authorisation holder: BARR
  • Status: supplemented

FDA — authorised 25 July 2001

  • Application: ANDA075671
  • Marketing authorisation holder: STRIDES PHARMA INTL
  • Status: supplemented

FDA — authorised 1 November 2004

  • Application: ANDA076721
  • Marketing authorisation holder: PHARMOBEDIENT
  • Status: supplemented

FDA — authorised 16 February 2006

  • Application: ANDA077404
  • Marketing authorisation holder: NOVITIUM PHARMA
  • Status: supplemented

FDA — authorised 27 August 2014

  • Application: ANDA203139
  • Marketing authorisation holder: TWI PHARMS
  • 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. Death — 833 reports (16.17%)
  2. Fatigue — 645 reports (12.52%)
  3. Diarrhoea — 591 reports (11.47%)
  4. Decreased Appetite — 523 reports (10.15%)
  5. Asthenia — 515 reports (10%)
  6. Nausea — 501 reports (9.73%)
  7. Pneumonia — 454 reports (8.81%)
  8. Dyspnoea — 426 reports (8.27%)
  9. Weight Decreased — 345 reports (6.7%)
  10. Pain — 318 reports (6.17%)

Source database →

Other Oncology approved in United States

Frequently asked questions

Is megestrol approved in United States?

Yes. FDA authorised it on 30 November 1995; FDA authorised it on 25 July 2001; FDA authorised it on 1 November 2004.

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

BARR holds the US marketing authorisation.