🇺🇸 MEDROXYPROGESTERONE ACETATE in United States

FDA authorised MEDROXYPROGESTERONE ACETATE on 18 June 1959 · 7,990 US adverse-event reports

Marketing authorisations

FDA — authorised 18 June 1959

  • Application: NDA011839
  • Marketing authorisation holder: PFIZER
  • Status: supplemented

FDA — authorised 29 October 1992

  • Application: NDA020246
  • Marketing authorisation holder: PFIZER
  • Status: supplemented

FDA — authorised 28 November 2017

  • Application: ANDA077334
  • Marketing authorisation holder: AMPHASTAR PHARMS INC
  • Status: approved

FDA — authorised 12 October 2018

  • Application: ANDA210227
  • Marketing authorisation holder: XIROMED
  • Status: approved

FDA — authorised 5 January 2023

  • Application: ANDA214309
  • Marketing authorisation holder: HIKMA
  • 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. Breast Cancer Female — 3,663 reports (45.84%)
  2. Breast Cancer — 2,069 reports (25.89%)
  3. Breast Cancer Metastatic — 444 reports (5.56%)
  4. Meningioma — 372 reports (4.66%)
  5. Drug Ineffective — 325 reports (4.07%)
  6. Oestrogen Receptor Assay Positive — 248 reports (3.1%)
  7. Off Label Use — 220 reports (2.75%)
  8. Ovarian Cancer — 220 reports (2.75%)
  9. Pain — 218 reports (2.73%)
  10. Progesterone Receptor Assay Positive — 211 reports (2.64%)

Source database →

MEDROXYPROGESTERONE ACETATE 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 MEDROXYPROGESTERONE ACETATE approved in United States?

Yes. FDA authorised it on 18 June 1959; FDA authorised it on 29 October 1992; FDA authorised it on 28 November 2017.

Who is the marketing authorisation holder for MEDROXYPROGESTERONE ACETATE in United States?

PFIZER holds the US marketing authorisation.