FEBUGET

Main information

  • Trade name:
  • FEBUGET 3*10 TAB
  • Dosage:
  • 80MG
  • Pharmaceutical form:
  • TAB
  • Composition:
  • 3*10
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FEBUGET 3*10 TAB
    India
  • Language:
  • English

Other information

Status

  • Source:
  • Central Drugs Standard Control Organization
  • Last update:
  • 09-08-2016

15-2-2018

Opinion/decision on a Paediatric investigation plan (PIP):    Adenuric, Febuxostat, Therapeutic area: Oncology

Opinion/decision on a Paediatric investigation plan (PIP): Adenuric, Febuxostat, Therapeutic area: Oncology

Europe - EFSA - European Food Safety Authority EFSA Journal

15-11-2017

Febuxostat (Brand Name Uloric): Drug Safety Communication - FDA to Evaluate Increased Risk of Heart-related Death

Febuxostat (Brand Name Uloric): Drug Safety Communication - FDA to Evaluate Increased Risk of Heart-related Death

Preliminary safety trial results in over 6,000 patients with gout being evaluated.

FDA - U.S. Food and Drug Administration

15-11-2017

FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

The U.S. Food and Drug Administration (FDA) is warning that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. We required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when we approved the medicine in 2009. Once we receive the final results from the manufacturer, we will conduct a comprehensive review and will update the public with any new inf...

FDA - U.S. Food and Drug Administration

21-4-2017

Pending EC decision:  Febuxostat Mylan, febuxostat, Opinion date: 21-Apr-2017

Pending EC decision: Febuxostat Mylan, febuxostat, Opinion date: 21-Apr-2017

Europe - EMA - European Medicines Agency

7-3-2018

Adenuric (Menarini International Operations Luxembourg S.A.)

Adenuric (Menarini International Operations Luxembourg S.A.)

Adenuric (Active substance: febuxostat) - PSUSA - Modification - Commission Decision (2018) 1483 of Wed, 07 Mar 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/777/PSUSA/1353/201704

Europe -DG Health and Food Safety

5-1-2018

ULORIC (Febuxostat) Tablet [Cardinal Health]

ULORIC (Febuxostat) Tablet [Cardinal Health]

Updated Date: Jan 5, 2018 EST

US - DailyMed

5-1-2018

FEBUXOSTAT Tablet [AbbVie Inc.]

FEBUXOSTAT Tablet [AbbVie Inc.]

Updated Date: Jan 5, 2018 EST

US - DailyMed

23-10-2017

ULORIC (Febuxostat) Tablet [Aphena Pharma Solutions - Tennessee, LLC]

ULORIC (Febuxostat) Tablet [Aphena Pharma Solutions - Tennessee, LLC]

Updated Date: Oct 23, 2017 EST

US - DailyMed

24-8-2017

ULORIC (Febuxostat) Tablet [Takeda Pharmaceuticals America, Inc.]

ULORIC (Febuxostat) Tablet [Takeda Pharmaceuticals America, Inc.]

Updated Date: Aug 24, 2017 EST

US - DailyMed

19-6-2017

Febuxostat Mylan (Mylan S.A.S.)

Febuxostat Mylan (Mylan S.A.S.)

Febuxostat Mylan (Active substance: febuxostat) - Centralised - Authorisation - Commission Decision (2017)4267 of Mon, 19 Jun 2017 European Medicines Agency (EMA) procedure number: EMEA/H/C/4374

Europe -DG Health and Food Safety