🇺🇸 The drug "Rutan 0.1". in United States

FDA authorised The drug "Rutan 0.1". on 28 October 1982 · 317,561 US adverse-event reports

Marketing authorisations

FDA — authorised 28 October 1982

  • Application: BLA018780
  • Marketing authorisation holder: LILLY
  • Status: supplemented

FDA — authorised 24 August 1995

  • Application: BLA020280
  • Marketing authorisation holder: PHARMACIA
  • Status: supplemented

FDA — authorised 2 June 2010

  • Application: ANDA090962
  • Marketing authorisation holder: P AND L
  • Status: supplemented

FDA — authorised 1 July 2010

  • Application: ANDA091314
  • Marketing authorisation holder: GLENMARK PHARMS INC
  • Status: supplemented

FDA — authorised 11 December 2017

  • Application: BLA209196
  • Marketing authorisation holder: SANOFI-AVENTIS US
  • Status: supplemented

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 — 60,381 reports (19.01%)
  2. Dry Skin — 43,642 reports (13.74%)
  3. Skin Burning Sensation — 39,945 reports (12.58%)
  4. Erythema — 38,597 reports (12.15%)
  5. Acne — 37,265 reports (11.73%)
  6. Skin Irritation — 24,668 reports (7.77%)
  7. Skin Exfoliation — 21,371 reports (6.73%)
  8. Rash — 19,113 reports (6.02%)
  9. Off Label Use — 17,024 reports (5.36%)
  10. Inappropriate Schedule Of Product Administration — 15,555 reports (4.9%)

Source database →

Other Virology/Infectious Disease approved in United States

Frequently asked questions

Is The drug "Rutan 0.1". approved in United States?

Yes. FDA authorised it on 28 October 1982; FDA authorised it on 24 August 1995; FDA authorised it on 2 June 2010.

Who is the marketing authorisation holder for The drug "Rutan 0.1". in United States?

LILLY holds the US marketing authorisation.