16036 Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Notices 

1This notice does not include a determination as 

to whether CITANEST FORTE, approved under 

NDA 14–763, was withdrawn for reasons of safety 

or efficacy. 

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4%, Were Not Withdrawn From Sale for 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. 

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withdrawn from sale for reasons of 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 (§ 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. 

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 

§ 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0226] 

Guidance for Industry, Third Parties 

and Food and Drug Administration 

Staff; Medical Device ISO 13485:2003 

Voluntary Audit Report Submission 

Pilot Program; Availability 

AGENCY: Food and Drug Administration, 

HHS. 


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