[Federal Register Volume 76, Number 141 (Friday, July 22, 2011)]
[Notices]
[Pages 44012-44013]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-18473]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2010-P-0577 and FDA-2010-P-0579]


Determination That NUVIGIL (Armodafinil) Tablets, 100 Milligrams 
and 200 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety 
or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that 
NUVIGIL (armodafinil) Tablets, 100 milligrams (mg) and 200 mg, were not 
withdrawn from sale for reasons of safety or effectiveness. This 
determination will allow FDA to approve abbreviated new drug 
applications (ANDAs) for armodafinil tablets, 100 mg and 200 mg, if all 
other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Molly Flannery, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6237, Silver Spring, MD 20993-0002, 301-
796-3543.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products under an ANDA procedure. ANDA applicants 
must, with certain exceptions, show that the drug for which they are 
seeking approval contains the same active ingredient in the same 
strength and dosage form as the ``listed drug,'' which is a version of 
the drug that was previously approved. ANDA applicants do not have to 
repeat the extensive clinical testing otherwise necessary to gain 
approval of a new drug application (NDA). The only clinical data 
required in an ANDA are data to show that the drug that is the subject 
of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which 
requires FDA to publish a list of all approved drugs. FDA publishes 
this list as part of the ``Approved Drug Products With Therapeutic 
Equivalence Evaluations,'' which is known generally as the ``Orange 
Book.'' Under FDA regulations, drugs are removed from the list if the 
Agency withdraws or suspends approval of the drug's NDA or ANDA for 
reasons of safety or effectiveness or if FDA determines that the listed 
drug was withdrawn from sale for reasons of safety or effectiveness (21 
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may 
determine on its own initiative, whether a listed drug was withdrawn 
from sale for reasons of safety or effectiveness. This determination 
may be made at any time after the drug has been withdrawn from sale, 
but must be made prior to approving an ANDA that refers to the listed 
drug (314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does 
not refer to a listed drug.
    NUVIGIL (armodafinil) Tablets, 100 mg and 200 mg, are the subject 
of NDA 21-875, held by Cephalon, Inc., and initially approved on June 
15, 2007. NUVIGIL is indicated to improve wakefulness in patients with 
excessive sleepiness associated with obstructive sleep apnea, 
narcolepsy, and shift work disorder.
    NUVIGIL (armodafinil) Tablets, 100 mg and 200 mg, are currently 
listed in the ``Discontinued Drug Product List'' section of the Orange 
Book.
    Actavis, Inc., submitted a citizen petition dated November 9, 2010 
(Docket No. FDA-2010-P-0579), under 21 CFR 10.30, requesting that the 
Agency determine that NUVIGIL (armodafinil) Tablets, 100 mg and 200 mg, 
were not voluntarily withdrawn for safety or efficacy reasons. Watson 
Laboratories, Inc., also submitted a

[[Page 44013]]

citizen petition dated November 9, 2010 (Docket No. FDA-2010-P-0577), 
under 21 CFR 10.30, requesting that the Agency determine whether 
NUVIGIL (armodafinil) Tablets, 100 mg and 200 mg, were withdrawn from 
sale for reasons of safety or effectiveness.
    After considering the citizen petitions and reviewing Agency 
records, FDA has determined under 314.161 that NUVIGIL (armodafinil) 
Tablets, 100 mg and 200 mg, were not withdrawn for reasons of safety or 
effectiveness. The petitioners have identified no data or other 
information suggesting that NUVIGIL (armodafinil) Tablets, 100 mg and 
200 mg, were withdrawn for reasons of safety or effectiveness. We have 
carefully reviewed our files for records concerning the withdrawal of 
NUVIGIL (armodafinil) Tablets, 100 mg and 200 mg, from sale. We have 
also independently evaluated relevant literature and data for possible 
postmarketing adverse events. We have found no information that would 
indicate that this product was withdrawn from sale for reasons of 
safety or effectiveness.
    Accordingly, the Agency will continue to list NUVIGIL (armodafinil) 
Tablets, 100 mg and 200 mg, in the ``Discontinued Drug Product List'' 
section of the Orange Book. The ``Discontinued Drug Product List'' 
delineates, among other items, drug products that have been 
discontinued from marketing for reasons other than safety or 
effectiveness. ANDAs that refer to NUVIGIL (armodafinil) Tablets, 100 
mg and 200 mg, may be approved by the Agency as long as they meet all 
other legal and regulatory requirements for the approval of ANDAs. If 
FDA determines that labeling for this drug product should be revised to 
meet current standards, the Agency will advise ANDA applicants to 
submit such labeling.

    Dated: July 18 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-18473 Filed 7-21-11; 8:45 am]
BILLING CODE 4160-01-P