Lipofen

NDA 21612, held by Cipher Pharms Inc. Fenofibrate.

As of Nov 14, 2026, NDA 21612 (Lipofen), held by Cipher Pharms Inc, was first approved by FDA on Jan 11, 2006, with 12 approved supplements and 0 published complete response letters.

First approved: Jan 11, 2006
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Fenofibrate capsules are indicated as adjunctive therapy to diet: to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Jan 11, 2006	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

3 strengths and forms


Lipofen50MG · capsule;oral	Fenofibrate	RxReference drug
Lipofen100MG · capsule;oral	Fenofibrate	DiscontinuedReference drug
Lipofen150MG · capsule;oral	Fenofibrate	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


Jun 6, 2025	Supplement 26Labeling · Standard review	Approved	Label Letter
Jun 3, 2021	Supplement 24Labeling	Approved	Letter Label
May 15, 2019	Supplement 20Labeling	Approved	Letter Label
Nov 6, 2018	Supplement 17Labeling · Standard review	Approved	Letter Label
May 18, 2018	Supplement 18Labeling	Approved	Letter Label
Dec 23, 2015	Supplement 16Manufacturing · Standard review	Approved	None posted
Jan 18, 2013	Supplement 13Manufacturing · Standard review	Approved	None posted
Jan 18, 2013	Supplement 14Manufacturing · Standard review	Approved	Letter Label
Jan 18, 2013	Supplement 15Labeling · Standard review	Approved	Letter Label
Oct 31, 2011	Supplement 7Labeling · Standard review	Approved	Letter Label
Dec 12, 2008	Supplement 2Manufacturing	Approved	Letter
Dec 12, 2008	Supplement 4Labeling · Standard review	Approved	Letter
Jan 11, 2006	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21612
Drugs@FDA: Overview at FDA
Company: Cipher Pharmaceuticals

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