🇺🇸 Periostat in United States

FDA authorised Periostat on 30 September 1998 · 81 US adverse-event reports

Marketing authorisations

FDA — authorised 30 September 1998

  • Application: NDA050744
  • Marketing authorisation holder: COLLAGENEX
  • Local brand name: PERIOSTAT
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA — authorised 2 February 2001

  • Application: NDA050783
  • Marketing authorisation holder: GALDERMA LABS LP
  • Local brand name: PERIOSTAT
  • Indication: TABLET — ORAL
  • 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. Pain — 11 reports (13.58%)
  2. Depression — 9 reports (11.11%)
  3. Arthralgia — 8 reports (9.88%)
  4. Chest Pain — 8 reports (9.88%)
  5. Dyspnoea — 8 reports (9.88%)
  6. Fall — 8 reports (9.88%)
  7. Insomnia — 8 reports (9.88%)
  8. Anxiety — 7 reports (8.64%)
  9. Cataract — 7 reports (8.64%)
  10. Fatigue — 7 reports (8.64%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Periostat approved in United States?

Yes. FDA authorised it on 30 September 1998; FDA authorised it on 2 February 2001.

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

COLLAGENEX holds the US marketing authorisation.