[Federal Register Volume 77, Number 53 (Monday, March 19, 2012)]
[Notices]
[Page 16036]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-6501]



[[Page 16036]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-P-0528]


Determination That CITANEST (Prilocaine Hydrochloride) Injection, 
1%, 2%, and 3%, and CITANEST PLAIN (Prilocaine Hydrochloride) 
Injection, 4%, Were Not Withdrawn From Sale for Reasons of Safety or 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 
CITANEST (prilocaine hydrochloride (HCl)) Injection, 1%, 2%, and 3%, 
and CITANEST PLAIN (prilocaine HCl) Injection, 4%, were not withdrawn 
from sale for reasons of safety or effectiveness. This determination 
will allow FDA to approve abbreviated new drug applications (ANDAs) for 
prilocaine HCl injection, 1%, 2%, and 3%, and prilocaine HCl injection, 
4%, if all legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: S. Mitchell Weitzman, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6318, Silver Spring, MD 20993-0002, 301-
796-3511.

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.
    CITANEST (prilocaine HCl) Injection, 1%, 2%, and 3%, and CITANEST 
PLAIN (prilocaine HCl) Injection, 4%, are the subject of NDA 14-763, 
held by AstraZeneca, and initially approved on November 18, 1965. 
CITANEST and CITANEST PLAIN are indicated for the production of local 
anesthesia in infiltration procedures, peripheral nerve blocks, and 
epidural or caudal blocks.
    In a letter dated August 28, 2002, AstraZeneca notified FDA that 
they had decided to withdraw NDA 14-763 for CITANEST (prilocaine HCl) 
Injection, 1%, 2%, and 3%; CITANEST PLAIN (prilocaine HCl) Injection, 
4%; and CITANEST FORTE (epinephrine bitartrate and prilocaine HCl) 
Injection, 0.005 milligrams/milliliter and 4%,\1\ in accordance with 21 
CFR 314.150(c). FDA moved the drug products to the ``Discontinued Drug 
Product List'' section of the Orange Book. In the Federal Register of 
August 18, 2003 (68 FR 49481), FDA announced that it was withdrawing 
approval of NDA 14-763, effective September 17, 2003.
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    \1\ This notice does not include a determination as to whether 
CITANEST FORTE, approved under NDA 14-763, was withdrawn for reasons 
of safety or efficacy.
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    Lachman Consultant Services, Inc., submitted a citizen petition 
dated September 25, 2008 (Docket No. FDA-2008-P-0528), under 21 CFR 
10.30, requesting that the Agency determine whether prilocaine HCl 
injections, 1%, 2%, 3%, and 4%, NDA 14-763, were withdrawn from sale 
for reasons of safety or effectiveness.
    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 CITANEST (prilocaine HCl) Injection, 1%, 2%, 
and 3%, and CITANEST PLAIN (prilocaine HCl) Injection, 4%, were not 
withdrawn for reasons of safety or effectiveness.
    The petitioner has identified no data or other information 
suggesting that CITANEST (prilocaine HCl) Injection, 1%, 2%, and 3%, 
and CITANEST PLAIN (prilocaine HCl) Injection, 4%, were withdrawn for 
reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of CITANEST (prilocaine 
HCl) Injection, 1%, 2%, and 3%, and CITANEST PLAIN (prilocaine HCl) 
Injection, 4%, 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 CITANEST 
(prilocaine HCl) Injections, 1%, 2%, and 3%, and CITANEST PLAIN 
(prilocaine HCl) Injection, 4%, were not withdrawn from sale for 
reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list CITANEST (prilocaine 
HCl) Injection, 1%, 2%, and 3%, and CITANEST PLAIN (prilocaine HCl) 
Injection, 4%, 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 
CITANEST (prilocaine HCl) Injection, 1%, 2%, and 3%, and CITANEST PLAIN 
(prilocaine HCl) Injection, 4%, 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 13, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6501 Filed 3-16-12; 8:45 am]
BILLING CODE 4160-01-P