[Federal Register Volume 77, Number 49 (Tuesday, March 13, 2012)]
[Notices]
[Pages 14810-14811]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-6039]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-P-0527]


Determination That DURANEST (Etidocaine Hydrochloride) Injection, 
0.5%, and Five Other DURANEST Drug Products Were Not Withdrawn From 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 the 
DURANEST (etidocaine hydrochloride) drug products listed in this 
document were not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow FDA to approve abbreviated 
new drug applications (ANDAs) that refer to these drug products if all 
other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Rachel Bressler, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6302, Silver Spring, MD 20993-0002, 301-
796-4288.

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 (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that 
does not refer to a listed drug.
    The drug products listed in the table in this document are no 
longer being marketed. DURANEST is indicated for infiltration 
anesthesia, peripheral nerve blocks (e.g., brachial plexus, intercostal 
retrobular, ulnar, inferior alveolar), and central nerve block (i.e., 
lumbar or caudal epidural blocks).

------------------------------------------------------------------------
                                                      Initial approval
 Application No.        Drug          Applicant             date
------------------------------------------------------------------------
NDA 17-751......  DURANEST         AstraZeneca      August 30, 1976.
                   (epinephrine     Pharmaceutical.
                   bitartrate;
                   etidocaine
                   hydrochloride)
                   Injection 1%.

[[Page 14811]]

 
Do..............  DURANEST         ......do.......   Do.
                   (epinephrine
                   bitartrate;
                   etidocaine
                   hydrochloride)
                   Injection 1.5%.
Do..............  DURANEST         ......do.......   Do.
                   (epinephrine;
                   etidocaine
                   hydrochloride)
                   Injection 0.5%.
Do..............  DURANEST         ......do.......   Do.
                   (etidocaine
                   hydrochloride)
                   Injection 0.5%.
Do..............  DURANEST         ......do.......   Do.
                   (etidocaine
                   hydrochloride)
                   Injection 1%.
NDA 21-384......  DURANEST         DENTSPLY          Do.
                   (epinephrine     Pharmaceutical.
                   bitartrate;
                   etidocaine
                   hydrochloride)
                   Injection 1.5%.
------------------------------------------------------------------------

    The drug products listed in the table in this document are 
currently listed in the ``Discontinued Drug Product List'' section of 
the Orange Book. Lachman Consultant Services, Inc. submitted a citizen 
petition dated September 25, 2008 (Docket No. FDA-2008-P-0527), under 
21 CFR 10.30, requesting that the Agency determine whether DURANEST 
(etidocaine hydrochloride) Injection, 0.5% and 1%, were withdrawn from 
sale for reasons of safety or effectiveness. Although the citizen 
petition did not request a determination for the other DURANEST drug 
products listed in the table in this document, those drug products have 
also been discontinued. On our own initiative, we have also determined 
whether those products were withdrawn for safety or effectiveness 
reasons.
    After considering the citizen petition and reviewing Agency records 
and based on the information we have at this time, FDA has determined 
under Sec.  314.161 that the DURANEST drug products listed in the table 
in this document were not withdrawn for reasons of safety or 
effectiveness. The petitioner has identified no data or other 
information suggesting that the DURANEST drug products were withdrawn 
for reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of the DURANEST drug 
products from sale. We have also independently evaluated relevant 
literature and data for possible postmarketing adverse events. We have 
reviewed the available evidence and determined that the products were 
not withdrawn from sale for reasons of safety or effectiveness. 
Accordingly, the Agency will continue to list the DURANEST drug 
products listed 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 any of the DURANEST drug products listed in the table in this 
document 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 these drug products should be revised to 
meet current standards, the Agency will advise ANDA applicants to 
submit such labeling.

    Dated: March 8, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6039 Filed 3-12-12; 8:45 am]
BILLING CODE 4160-01-P