[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]
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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Micrograms, Was Not Withdrawn From Sale for Reasons of Safety or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.
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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withdrawn from sale for reasons of safety or effectiveness.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]
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