🇺🇸 Multiple cardiovascular drugs related to "Golden Triangle" in United States

FDA authorised Multiple cardiovascular drugs related to "Golden Triangle" on 7 June 2010 · 368,556 US adverse-event reports

Marketing authorisations

FDA — authorised 7 June 2010

  • Application: ANDA065496
  • Marketing authorisation holder: ALKEM LABS LTD
  • Status: supplemented

FDA — authorised 10 June 2010

  • Application: ANDA090314
  • Marketing authorisation holder: ONESOURCE SPECIALTY
  • Status: approved

FDA — authorised 28 July 2017

  • Application: ANDA205327
  • Marketing authorisation holder: OSMOTICA PHARM US
  • Status: approved

FDA — authorised 4 September 2019

  • Application: ANDA208058
  • Marketing authorisation holder: HERITAGE PHARMA AVET
  • Status: approved

FDA — authorised 10 December 2020

  • Application: ANDA212977
  • Marketing authorisation holder: XIROMED
  • Status: supplemented

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. Nausea — 44,902 reports (12.18%)
  2. Fatigue — 43,214 reports (11.73%)
  3. Pain — 41,550 reports (11.27%)
  4. Drug Ineffective — 40,675 reports (11.04%)
  5. Diarrhoea — 37,470 reports (10.17%)
  6. Drug Dependence — 35,334 reports (9.59%)
  7. Dyspnoea — 32,797 reports (8.9%)
  8. Off Label Use — 31,709 reports (8.6%)
  9. Headache — 31,368 reports (8.51%)
  10. Vomiting — 29,537 reports (8.01%)

Source database →

Multiple cardiovascular drugs related to "Golden Triangle" 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 Multiple cardiovascular drugs related to "Golden Triangle" approved in United States?

Yes. FDA authorised it on 7 June 2010; FDA authorised it on 10 June 2010; FDA authorised it on 28 July 2017.

Who is the marketing authorisation holder for Multiple cardiovascular drugs related to "Golden Triangle" in United States?

ALKEM LABS LTD holds the US marketing authorisation.