Farydak

NDA 205353, held by Secura. Panobinostat Lactate.

As of Nov 15, 2026, NDA 205353 (Farydak), held by Secura, was first approved by FDA on Feb 23, 2015, with 1 approved supplement and 0 published complete response letters.

First approved: Feb 23, 2015
Review: Priority
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Feb 23, 2015	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Other Letter

Products

3 strengths and forms


FarydakEQ 10MG BASE · capsule;oral	Panobinostat Lactate	DiscontinuedReference drug
FarydakEQ 15MG BASE · capsule;oral	Panobinostat Lactate	DiscontinuedReference drug
FarydakEQ 20MG BASE · capsule;oral	Panobinostat Lactate	DiscontinuedReference drug

All 2 submissions, including labeling and manufacturing supplements


Jun 6, 2016	Supplement 1Labeling · Standard review	Approved	Letter
Feb 23, 2015	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Other Letter

Identifiers

Application: NDA 205353
Drugs@FDA: Overview at FDA
Company: Secura Bio

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters