[Federal Register Volume 76, Number 69 (Monday, April 11, 2011)]
[Notices]
[Pages 19997-19998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8524]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-P-0593]


Determination That FENTORA (Fentanyl Citrate) Buccal Tablet, 300 
Micrograms, Was Not Withdrawn From Sale for Reasons of Safety or 
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined that 
FENTORA (fentanyl citrate) buccal tablet, 300 micrograms (mcg), was not 
withdrawn from sale for reasons of safety or effectiveness. This 
determination will allow FDA to approve abbreviated new drug 
applications (ANDAs) for fentanyl citrate buccal tablet, 300 mcg, if 
all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Reena Raman, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6238, Silver Spring, MD 20993-0002, 301-
796-7577.

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 approved 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). Under Sec.  314.161(a)(1) (21 CFR 314.161(a)(1)), the 
Agency must determine whether a listed drug was withdrawn from sale for 
reasons of safety or effectiveness before an ANDA that refers to that 
listed drug may be approved. FDA may not approve an ANDA that does not 
refer to a listed drug.
    FENTORA (fentanyl citrate) buccal tablet, 300 mcg, is the subject 
of NDA 21-947, held by Cephalon, Inc., and initially approved on 
September 25, 2006. FENTORA is indicated for the management of 
breakthrough pain in

[[Page 19998]]

patients with cancer who are already receiving and who are tolerant to 
around-the-clock opioid therapy for their underlying persistent cancer 
pain.
    FENTORA (fentanyl citrate) buccal tablet, 300 mcg, is currently 
listed in the ``Discontinued Drug Product List'' section of the Orange 
Book.
    Watson Laboratories, Inc., submitted a citizen petition dated 
November 16, 2010 (Docket No. FDA-2010-P-0593), under 21 CFR 10.30, 
requesting that the Agency determine whether FENTORA (fentanyl citrate) 
buccal tablet, 300 mcg, was withdrawn from sale for reasons of safety 
or effectiveness.
    After considering the citizen petition and reviewing Agency 
records, FDA has determined under Sec.  314.161 that FENTORA (fentanyl 
citrate) buccal tablet, 300 mcg, was not withdrawn for reasons of 
safety or effectiveness. The petitioner has identified no data or other 
information suggesting that FENTORA (fentanyl citrate) buccal tablet, 
300 mcg, was withdrawn for reasons of safety or effectiveness. We have 
carefully reviewed our files for records concerning the withdrawal of 
FENTORA (fentanyl citrate) buccal tablet, 300 mcg, from sale. We have 
also independently evaluated relevant literature and data for possible 
postmarketing adverse events and 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 FENTORA (fentanyl 
citrate) buccal tablet, 300 mcg, 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 FENTORA (fentanyl citrate) buccal 
tablet, 300 mcg, 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: April 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8524 Filed 4-8-11; 8:45 am]
BILLING CODE 4160-01-P