Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 52357 

1On December 17, 1999, FDA approved NDAs 

21–061 and 21–062 for community-acquired 

pneumonia, acute bacterial exacerbation of chronic 

bronchitis, acute bacterial sinusitis, uncomplicated 

urinary tract infections, complicated urinary tract 

infections, pyelonephritis, and uncomplicated 

gonorrhea. The December 17, 1999, approval letter 

also stated that indications for uncomplicated skin 

and skin structure infections were approvable 

pending the submission of certain postmarketing 

data. For administrative purposes, the agency 

assigned administrative NDAs 21–404 (TEQUIN 

Tablets) and 21–405 (TEQUIN Injections) for the 

treatment of uncomplicated skin and skin structure 

infections. BMS provided a complete response, and 

upon approval on October 17, 2002, NDAs 21–404 

and 21–405 were retired by FDA. The approvals 

and all other submissions for the treatment of 

uncomplicated skin and skin structure infections 

were incorporated in the original NDAs, 21–061 

and 21–062. NDAs 21–404 and 21–405 are not 

listed in the Orange Book, but can be found through 

a search at Drugs@FDA. 

scheduled for the meeting; or you may 

contact the Board’s Web site at http:// 

www.federalreserve.gov for an electronic 

announcement that not only lists 

applications, but also indicates 

procedural and other information about 

the meeting. 

Board of Governors of the Federal Reserve 

System, September 5, 2008. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. E8–20989 Filed 9–5–08; 4:15 pm] 

BILLING CODE 6210–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2006–P–0081 (formerly 

Docket No. 2006P–0178) and FDA–2005–P–

0369 (formerly Docket No. 2005P–0023)] 

Determination That TEQUIN 

(Gatifloxacin) Was Withdrawn From 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 TEQUIN (gatifloxacin) Tablets, 

Injection, and Oral Suspension, were 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination means that FDA will not 

accept or approve abbreviated new drug 

applications (ANDAs) for gatifloxacin 

oral tablets, injection, or oral suspension 

that refer to any previously approved 

dosage forms and strengths of TEQUIN 

(gatifloxacin). 

FOR FURTHER INFORMATION CONTACT: 

Elena Cohen, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, rm. 6228, Silver Spring, 

MD 20993–0002, 301–796–3602. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Public Law 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 under a new drug 

application (NDA). ANDA applicants do 

not have to repeat the extensive clinical 

testing otherwise necessary to gain 

approval of an 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 (the 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 generally known as the 

‘‘Orange Book.’’ 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 

(section 505(j)(7)(C) of the act; § 314.162 

(21 CFR 314.162)). 

FDA will not approve an ANDA if the 

listed drug has been withdrawn from 

sale for safety or effectiveness reasons 

(section 505(j)(4)(I) of the act). Under 

§ 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. A drug that has been 

withdrawn from the market for safety or 

effectiveness reasons is not a listed drug 

(21 CFR 314.3(b)). FDA may not approve 

an ANDA that does not refer to a listed 

drug. FDA currently has pending one or 

more ANDAs that refer to TEQUIN 

(gatifloxacin). 

Bristol-Myers Squibb Co. (BMS) is the 

holder of three NDAs1 for TEQUIN 

tablets, injection, and oral suspension as 

listed in the following table: 

TABLE 1.—APPROVED TEQUIN PRODUCTS

NDA No. Active Ingredients Strength Dosage Form/Route 

21–061 Gatifloxacin 200 milligrams (mg) Tablet; oral 

21–061 Gatifloxacin 400 mg Tablet; oral 

21–062 Gatifloxacin Equivalent to 10 mg/milliliter (mL) (200 mg) Injectable; injection 

21–062 Gatifloxacin 400 mg/40 mL (10 mg/mL) Injectable; injection 

21–062 Gatifloxacin in dextrose 5% in 

plastic container 

200 mg/100 mL (2 mg/mL) Injectable; injection 

21–062 Gatifloxacin in dextrose 5% in 

plastic container 

400 mg/200mL (2 mg/mL) Injectable; injection 

21–678 Gatifloxacin 200 mg/5 mL Suspension; oral 

TEQUIN is an antibacterial drug 

indicated for the treatment of infections 

due to susceptible strains of designated 

microorganisms in the following 

conditions: Acute bacterial exacerbation 

of chronic bronchitis; acute sinusitis; 


jlentini on PROD1PC65 with NOTICES
52358 Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 

2This citizen petition was originally assigned 

docket number 2005P–0023/CP1. The number was 

changed to FDA–2005–P–0369 as a result of FDA’s 

transition to its new docketing system 

(Regulations.gov) in January 2008. 

3This citizen petition was originally assigned 

docket number 2006P–0178. The number was 

changed to FDA–2006–P–0081 as a result of FDA’s 

transition to its new docketing system 

(Regulations.gov) in January 2008. 

community-acquired pneumonia; 

uncomplicated skin and skin structure 

infections; uncomplicated and 

complicated urinary tract infections; 

pyelonephritis; uncomplicated urethral 

and cervical gonorrhea; and acute, 

uncomplicated rectal infections in 

women. 

In January 2003, FDA received revised 

product labeling relating to several 

approved supplements for TEQUIN 

(gatifloxacin). This revised labeling 

deleted references to TEQUIN injection, 

10 milligrams/milliliter (mg/mL) (200 

mg), indicating that this product was no 

longer being marketed; therefore, the 

product was moved from the 

prescription drug product list to the 

‘‘Discontinued Drug Product List’’

section of the Orange Book. In response 

to a citizen petition from Apotex Corp. 

(Docket No. FDA–2005–P–0369),2 FDA 

stated, in the Federal Register of 

February 3, 2006 (71 FR 5858), that 

TEQUIN injection, 10 mg/mL (200 mg), 

was not withdrawn for reasons of safety 

and effectiveness. 

On May 1, 2006, Public Citizen 

Research Group submitted a citizen 

petition (Docket No. FDA–2006–P–

0081),3 under 21 CFR 10.30, requesting 

that FDA immediately ban TEQUIN 

because of the increased risk of 

dysglycemia (hypoglycemia, low blood 

sugar, and hyperglycemia, high blood 

sugar) in humans. Public Citizen states 

that it reached its conclusion based on: 

(1) The relatively high numbers and 

rates of gatifloxacin-associated 

dysglycemia adverse event reports 

calculated from data collected by FDA’s 

Adverse Event Reporting System (AERS) 

and Health Canada’s Adverse Drug 

Reaction Monitoring Program; (2) a 

study by Park-Wyllie et al., published in 

March 2006 in the New England Journal 

of Medicine, that showed that patients 

(diabetic and nondiabetic) receiving 

gatifloxacin had approximately 17 times 

the odds of having a hyperglycemic 

episode and 4 times the odds of having 

a hypoglycemic episode compared to 

those taking macrolide antibiotics; and 

(3) the relatively high numbers and rates 

of gatifloxacin-associated dysglycemic 

events in the manufacturer’s safety 

studies in uninfected patients and other 

studies in infected patients, including 

clinical trials, cohort studies, casecontrol studies, postmarketing 

surveillance studies, and case reports. 

In June 2006, BMS announced that it 

would no longer market TEQUIN. In 

light of pending ANDAs and the citizen 

petition, FDA examined whether all 

TEQUIN products, including TEQUIN 

(gatifloxacin) injection, 10 mg/mL (200 

mg), were withdrawn from the market 

for reasons of safety or effectiveness. 

After considering the citizen petition 

and reviewing agency records 

concerning the drug product, analyses 

of AERS reports, and relevant literature, 

FDA has determined under § 314.161 

that TEQUIN was withdrawn from sale 

for reasons of safety or effectiveness. 

Accordingly, the agency will remove all 

TEQUIN products from the Orange Book 

(§ 314.162). FDA will not accept or 

approve ANDAs that refer to these drug 

products. 

Therefore, the agency has determined, 

under § 314.161, that all dosage forms 

and strengths of TEQUIN (gatifloxacin) 

listed in the table of this document were 

withdrawn from sale for reasons of 

safety. TEQUIN (gatifloxacin) will be 

removed from the list of drug products 

published in the Orange Book. FDA will 

not accept or approve ANDAs that refer 

to any dosage form or strength of 

TEQUIN (gatifloxacin). 

Dated: September 2, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–20938 Filed 9–8–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2004–N–0451] (formerly 

FDA–2004–N–0226) 

Food and Drug Administration 

Modernization Act of 1997: 

Modifications to the List of Recognized 

Standards, Recognition List Number: 

020 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

publication containing modifications 

the agency is making to the list of 

standards FDA recognizes for use in 

premarket reviews (FDA recognized 

consensus standards). This publication, 

entitled ‘‘Modifications to the List of 

Recognized Standards, Recognition List 

Number: 020’’ (Recognition List 

Number: 020), will assist manufacturers 

who elect to declare conformity with 

consensus standards to meet certain 

requirements for medical devices. 

DATES: Effective September 9, 2008. 

Submit written or electronic comments 

concerning this document at any time. 

ADDRESSES: Submit written requests for 

single copies of ‘‘Modifications to the 

List of Recognized Standards, 

Recognition List Number: 020’’ to the 

Division of Small Manufacturers, 

International and Consumer Assistance, 

Center for Devices and Radiological 

Health (CDRH) (HFZ–220), Food and 

Drug Administration, 1350 Piccard Dr., 

Rockville, MD 20850. Send two selfaddressed adhesive labels to assist that 

office in processing your requests, or fax 

your request to 240–276–3151. Submit 

written comments concerning this 

document, or recommendations for 

additional standards for recognition, to 

the contact person (see FOR FURTHER

INFORMATION CONTACT). Submit 

electronic comments to 

standards@cdrh.fda.gov. This document 

may also be accessed on FDA’s Internet 

site at http://www.accessdata.fda.gov/ 

scripts/cdrh/cfdocs/cfTopic/ 

cdrhnew.cfm. See section VI of this 

document for electronic access to the 

searchable database for the current list 

of FDA recognized consensus standards, 

including Recognition List Number: 020 

modifications and other standards 

related information. 

FOR FURTHER INFORMATION CONTACT: 

Carol L. Herman, Center for Devices and 

Radiological Health (HFZ–84), Food and 

Drug Administration, 7520 Standish Pl., 

Rockville, MD 20855, 240–276–8714. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 204 of the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA) (Public Law 105–115) 

amended section 514 of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 360d). Amended section 514 

allows FDA to recognize consensus 

standards developed by international 

and national organizations for use in 

satisfying portions of device premarket 

review submissions or other 

requirements. 

In a notice published in the Federal 

Register of February 25, 1998 (63 FR 

9561), FDA announced the availability 

of a guidance entitled ‘‘Recognition and 

Use of Consensus Standards.’’ The 

document described how FDA would 

implement its standard recognition 

program and provided the initial list of 

recognized standards. 

Modifications to the initial list of 

recognized standards, as published in 


jlentini on PROD1PC65 with NOTICES