Nuvigil

For excessive sleepiness associated with obstructive sleep apnea (OSA). NDA 21875, held by Nuvo Pharms. Armodafinil.

As of Nov 14, 2026, NDA 21875 (Nuvigil), held by Nuvo Pharms, was first approved by FDA on Jun 15, 2007, with 12 approved supplements and 0 published complete response letters.

First approved: Jun 15, 2007
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

NUVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use In OSA, NUVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating NUVIGIL for excessive sleepiness.

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
Jun 15, 2007	Original applicationNew formulation or manufacturer · Standard review	Approved	Medication Guide Review Letter Label

Products

5 strengths and forms


Nuvigil50MG · tablet;oral	Armodafinil	RxReference drug
Nuvigil100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Armodafinil	DiscontinuedReference drug
Nuvigil150MG · tablet;oral	Armodafinil	RxReference drug
Nuvigil250MG · tablet;oral	Armodafinil	RxReference drug
Nuvigil200MG · tablet;oral	Armodafinil	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


Feb 7, 2017	Supplement 23Labeling · Standard review	Approved	Letter Label
Apr 16, 2015	Supplement 21Labeling · Standard review	Approved	Letter Label
Feb 9, 2015	Supplement 20Manufacturing · Standard review	Approved	None posted
Aug 23, 2013	Supplement 19Manufacturing · Standard review	Approved	None posted
Jun 28, 2013	Supplement 12Labeling	Approved	Label Letter
Apr 5, 2013	Supplement 18Manufacturing · Standard review	Approved	None posted
Jan 13, 2012	Supplement 16Labeling · Standard review	Approved	Letter
Jan 13, 2012	Supplement 17REMS	Approved	Letter
Oct 21, 2010	Supplement 5Labeling · Standard review	Approved	Label Letter
Oct 21, 2010	Supplement 8Labeling · Standard review	Approved	Label Letter
Oct 21, 2010	Supplement 15Labeling	Approved	Label Letter
Mar 26, 2009	Supplement 6Manufacturing	Approved	Letter
Jun 15, 2007	Original applicationNew formulation or manufacturer · Standard review	Approved	Medication Guide Review Letter Label

Identifiers

Application: NDA 21875
Drugs@FDA: Overview at FDA
Company: Nuvo 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