Panobinostat Lactate

Sold as Farydak. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Panobinostat Lactate (sold as Farydak), first approved Feb 23, 2015, with 0 new uses approved and 0 published complete response letters.

First approved: Feb 23, 2015
Applications: 1
New uses approved: 0
Complete response letters: 0
First approved in the EU: Aug 28, 2015
First approved in Japan: Jul 3, 2015

Orphan Designations (FDA)

3 designations, 1 approved for the designated use; see all orphan designations

Treatment of multiple myelomazr pharma& GmbH · designated Aug 20, 2012 · approved Feb 23, 2015
Treatment of Hodgkin's lymphomaNovartis Pharmaceuticals Corporation · designated Sep 18, 2009
Treatment of cutaneous T-cell lymphomaNovartis Pharmaceuticals Corporation · designated Sep 26, 2007

Approvals in the EU (EMA)

First approved in the EU 6 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Farydak, new substancepharmaand GmbH · Aug 28, 2015

Approvals in Japan (PMDA)

First approved in Japan 4 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Farydak, new ingredientDrugs with a new active ingredient indicated for the treatment of relapsed or refractory multiple myeloma. · Novartis Pharma K.K. · Jul 3, 2015 · Review report

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Study of Panobinostat (LBH589) in Patients With Sickle Cell DiseaseSickle Cell Disease · Abdullah Kutlar	Phase 1	Recruiting	Nov 22, 2010

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Feb 23, 2015	FarydakNDA 205353 · New molecular entity	Secura	1	Discontinued

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