🇺🇸 SALMETEROL in United States

FDA authorised SALMETEROL on 24 August 2000 · 16,400 US adverse-event reports

Marketing authorisations

FDA — authorised 24 August 2000

  • Application: NDA021077
  • Marketing authorisation holder: GLAXO GRP LTD
  • Status: supplemented

FDA — authorised 8 June 2006

  • Application: NDA021254
  • Marketing authorisation holder: GLAXO GRP LTD
  • Status: supplemented

FDA — authorised 27 January 2017

  • Application: NDA208799
  • Marketing authorisation holder: TEVA PHARM
  • Status: approved

FDA — authorised 17 December 2020

  • Application: ANDA203433
  • Marketing authorisation holder: HIKMA
  • Status: supplemented

FDA — authorised 13 December 2021

  • Application: ANDA213948
  • Marketing authorisation holder: TEVA PHARMS USA
  • 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. Asthma — 3,275 reports (19.97%)
  2. Dyspnoea — 2,679 reports (16.34%)
  3. Drug Ineffective — 2,060 reports (12.56%)
  4. Product Dose Omission Issue — 1,573 reports (9.59%)
  5. Cough — 1,364 reports (8.32%)
  6. Wheezing — 1,239 reports (7.55%)
  7. Pneumonia — 1,108 reports (6.76%)
  8. Headache — 1,093 reports (6.66%)
  9. Off Label Use — 1,075 reports (6.55%)
  10. Nausea — 934 reports (5.7%)

Source database →

SALMETEROL 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 SALMETEROL approved in United States?

Yes. FDA authorised it on 24 August 2000; FDA authorised it on 8 June 2006; FDA authorised it on 27 January 2017.

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

GLAXO GRP LTD holds the US marketing authorisation.