Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Sold as Incivek. Every FDA application for this active ingredient.
As of Nov 13, 2026, FDA lists 1 application for Telaprevir (sold as Incivek), first approved May 23, 2011, with 1 new use approved and 0 published complete response letters.
First approved: May 23, 2011
Applications: 1
New uses approved: 1
Complete response letters: 0
First approved in the EU: Sep 19, 2011
First approved in Japan: Sep 26, 2011
Approvals in the EU (EMA)
First approved in the EU 4 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals
First approved in Japan 4 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
TelavicA drug with a new additional indication for the improvement of viremia in serogroup 2 (genotype III [2a] or IV [2b]) chronic hepatitis C in patients who did… · Mitsubishi Tanabe Pharma Corporation · Sep 19, 2014
Telavic, new ingredientA drug with a new active ingredient indicated for the improvement of viremia in serogroup 1 (genotype I [1a] or II [1b]) chronic hepatitis C in: (1)… · Mitsubishi Tanabe Pharma Corporation · Sep 26, 2011
Applications
NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history
Approved
Application
Sponsor
Supplements
Marketing
May 23, 2011
IncivekNDA 201917 · New molecular entity, new combination
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
