Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices 45937 

Docket; Request for Comments.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ FDA 

will review this copy, including the 

claimed confidential information, in its 

consideration of comments. The second 

copy, which will have the claimed 

confidential information redacted/ 

blacked out, will be available for public 

viewing and posted on https://

www.regulations.gov. Submit both 

copies to the Dockets Management Staff. 

If you do not wish your name and 

contact information be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify the information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Jay 

R. Fajiculay, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, Rm. 2417, Silver Spring, 

MD 20993–0002, 301–796–9001, Fax: 

301–847–8533, email: GIDAC@

fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

FDA’s website at https://www.fda.gov/ 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before coming to the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The committee will discuss 

new drug application (NDA) 210166 for 

prucalopride tablets for oral 

administration, submitted by Shire 

Development, LLC, proposed for the 

treatment of chronic idiopathic 

constipation in adults. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s website after 

the meeting. Background material is 

available at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. All electronic and 

written submissions submitted to the 

Docket (see ADDRESSES) on or before 

October 9, 2018, will be provided to the 

committee. Oral presentations from the 

public will be scheduled between 

approximately 1 p.m. and 2 p.m. Those 

individuals interested in making formal 

oral presentations should notify the 

contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before October 1, 2018. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by October 2, 2018. 

Persons attending FDA’s advisory 

committee meetings are advised that 

FDA is not responsible for providing 

access to electrical outlets. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Jay Fajiculay 

(see FOR FURTHER INFORMATION CONTACT) 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: September 4, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19670 Filed 9–10–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3031] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Tobacco Products, 

User Fees, Requirements for the 

Submission of Data Needed To 

Calculate User Fees for Domestic 

Manufacturers and Importers of 

Tobacco Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection for tobacco product user fees. 


daltland on DSKBBV9HB2PROD with NOTICES
45938 Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices 

DATES: Submit either electronic or 

written comments on the collection of 

information by November 13, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before November 13, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of November 13, 2018. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–N–3031 for ‘‘Tobacco Products, 

User Fees, Requirements for the 

Submission of Data Needed to Calculate 

User Fees for Domestic Manufacturers 

and Importers of Tobacco Products.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Tobacco Products, User Fees, 

Requirements for the Submission of 

Data Needed To Calculate User Fees for 

Domestic Manufacturers and Importers 

of Tobacco Products 

OMB Control Number 0910–0749— 

Extension 

On June 22, 2009, the President 

signed the Family Smoking Prevention 

and Tobacco Control Act (the Tobacco 

Control Act) (Pub. L. 111–31) into law. 

The Tobacco Control Act amended the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) and granted FDA authority 

to regulate the manufacture, marketing, 

and distribution of tobacco products to 

protect public health generally and to 

reduce tobacco use by minors. 

FDA issued a final rule that requires 

domestic manufacturers and importers 

of cigars and pipe tobacco to submit 

information needed to calculate the 

amount of user fees assessed under the 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices 45939 

FD&C Act. FDA expanded its authority 

over tobacco products by issuing 

another final rule, ‘‘Deeming Tobacco 

Products To Be Subject to the Federal 

Food, Drug, and Cosmetic Act, as 

Amended by the Family Smoking 

Prevention and Tobacco Control Act; 

Restrictions on the Sale and Distribution 

of Tobacco Products and Required 

Warning Statements for Tobacco 

Products’’ (Deeming rule), deeming all 

products that meet the statutory 

definition of ‘‘tobacco product,’’ except 

accessories of the newly deemed 

tobacco products, to be subject to the 

FD&C Act. The Deeming rule, among 

other things, subjected domestic 

manufacturers and importers of cigars 

and pipe tobacco to the FD&C Act’s user 

fee requirements. Consistent with the 

Deeming rule and the requirements of 

the FD&C Act, the user fee final rule 

requires the submission of the 

information needed to calculate user fee 

assessments for each manufacturer and 

importer of cigars and pipe tobacco to 

FDA. 

As noted, FDA issued a final rule that 

requires domestic tobacco product 

manufacturers and importers to submit 

information needed to calculate the 

amount of user fees assessed under the 

FD&C Act. The U. S. Department of 

Agriculture (USDA) had been collecting 

this information and provided FDA with 

the data the Agency needed to calculate 

the amount of user fees assessed to 

tobacco product manufacturers and 

importers. USDA ceased collecting this 

information in fiscal year 2015 (October 

2014). USDA’s information collection 

did not require OMB approval, per an 

exemption by Public Law 108–357, 

section 642(b)(3). Consistent with the 

requirements of the FD&C Act, FDA 

requires the submission of this 

information to FDA now instead of 

USDA. FDA took this action to ensure 

that the Agency continues to have the 

information needed to calculate, assess, 

and collect user fees from domestic 

manufacturers and importers of tobacco 

products. 

Section 919(a) of the FD&C Act (21 

U.S.C. 387s(a)) requires FDA to ‘‘assess 

user fees on, and collect such fees from, 

each manufacturer and importer of 

tobacco products’’ subject to the tobacco 

product provisions of the FD&C Act 

(chapter IX of the FD&C Act). The total 

amount of user fees to be collected for 

each fiscal year is specified in section 

919(b)(1) of the FD&C Act, and under 

section 919(a) FDA is to assess and 

collect a proportionate amount each 

quarter of the fiscal year. The FD&C Act 

provides for the total assessment to be 

allocated among the classes of tobacco 

products. The class allocation is based 

on each tobacco product class’ volume 

of tobacco product removed into 

commerce. Within each class of tobacco 

products, an individual domestic 

manufacturer or importer is assessed a 

user fee based on its share of the market 

for that tobacco product class. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Hours per 

response 

Total 

hours 

1150.5(a), (b)(1) and (2), and Form FDA 3852; General 

identifying information provided by manufacturers and 

importers of FDA regulated tobacco products and identification and removal information (monthly) ...................... 658 12 7,896 3 23,688 

1150.5(b)(3); Certified copies (monthly) .............................. 658 12 7,896 1 7,896 

1150.13; Submission of user fee information (Identifying 

information, fee amount, etc. (quarterly) .......................... 329 4 1,316 1 1,316 

1150.15(a); Submission of user fee dispute (annually) ....... 5 1 5 10 50 

1150.15(d); Submission of request for further review of 

dispute of user fee (annually) .......................................... 3 1 3 10 30 

Total .............................................................................. ........................ ........................ ........................ ........................ 32,980 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

FDA estimates that 658 entities will 

submit tobacco product user fees. The 

entity count was derived from aggregate 

data provided by the Alcohol and 

Tobacco Tax and Trade Bureau (TTB), 

and reflects that in 2017 there were 192 

total permitted manufacturers and 466 

permitted importers over all tobacco 

product types for which TTB collects 

excise taxes (including cigarettes, cigars, 

snuff, chewing tobacco, pipe tobacco, 

and roll-your-own tobacco, excluding 

electronic nicotine delivery systems). 

The estimate of 658 respondents to 

provide the information requested from 

§ 1150.5(a), (b)(1) and (2) (21 CFR 

1150.5(a), (b)(1) and (2)), and Form FDA 

3852 reflects both reports of no removal 

of tobacco products into domestic 

commerce and reports of removal of 

tobacco product into domestic 

commerce. FDA estimates it will take 3 

hours for each of these submission types 

for a total of 23,688 hours. Under 

§ 1150.5(b)(3), these respondents are 

also expected to provide monthly 

certified copies of the returns and forms 

that relate to the removal of tobacco 

products into domestic commerce and 

the payment of Federal excise taxes 

imposed under chapter 52 of the 

Internal Revenue Code of 1986 to FDA. 

We estimate that each monthly report 

will take 1 hour for a total of 7,896 

hours. The estimate of 329 respondents 

to submit payment of user fee 

information under § 1150.13 reflects an 

average of half the number of domestic 

manufacturers and importers who may 

be subject to fees each fiscal quarter. 

FDA estimates the quarterly submission 

will take approximately 1 hour for a 

total of 1,316 hours. 

FDA estimates that five of those 

respondents assessed user fees will 

dispute the amounts under § 1150.15(a), 

for a total amount of 50 hours. FDA also 

estimates that three respondents who 

dispute their user fees will ask for 

further review by FDA under 

§ 1150.15(d), for a total amount of 30 

hours. FDA has only received one 

dispute submission since fiscal year 

2015. Based on this data, the Agency 

does not believe we will receive more 

than five disputes and three requests for 

further reviews in the next 3 years. 

FDA estimates the total annual 

burden for this collection of information 

is 32,980 hours. The estimated burden 

for the information collection reflects an 

overall increase of 16,058 hours. We 


daltland on DSKBBV9HB2PROD with NOTICES
45940 Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices 

1On May 26, 2011, Bristol-Myers Squibb 

transferred ownership of NDA 050664 and NDA 

050665 to Corden Pharma Latina S.p.A. 

attribute this adjustment to an increase 

in the number of entities submitting 

tobacco user fee information to FDA. 

Dated: September 4, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19664 Filed 9–10–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3262] 

Determination That CEFZIL (Cefprozil) 

Tablets, 250 Milligrams and 500 

Milligrams, and for Oral Suspension, 

125 Milligrams/5 Milliliters and 250 

Milligrams/5 Milliliters, 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 or Agency) has 

determined that CEFZIL (cefprozil) 

tablets, 250 milligrams (mg) and 500 mg 

and CEFZIL (cefprozil) for oral 

suspension, 125 mg/5 milliliters (mL) 

and 250 mg/5 mL were not withdrawn 

from sale for reasons of safety or 

effectiveness. This determination will 

allow FDA to continue to approve 

abbreviated new drug applications 

(ANDAs) that refer to these drugs as 

long as they meet relevant legal and 

regulatory requirements. 

FOR FURTHER INFORMATION CONTACT: 

Diana J. Pomeranz, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6288, 

Silver Spring, MD 20993–0002, 240– 

402–4654. 

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 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

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. 

Under § 314.161(a)(2), the Agency 

must also determine whether a listed 

drug was withdrawn from sale for 

reasons of safety or effectiveness if 

ANDAs that referred to the listed drug 

have already been approved prior to its 

market withdrawal. If the Agency 

determines that a listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness, and there are 

approved ANDAs that reference that 

listed drug, FDA will initiate a 

proceeding to determine whether the 

suspension of the ANDAs is also 

required (21 CFR 314.153(b)). 

CEFZIL (cefprozil) tablets, 250 mg and 

500 mg, are the subject of NDA 050664 

held by Corden Pharma Latina S.p.A., 

and initially approved on December 23, 

1991. CEFZIL (cefprozil) for oral 

suspension, 125 mg/5 mL and 250 mg/ 

5 mL, is the subject of NDA 050665 held 

by Corden Pharma Latina S.p.A., and 

initially approved on December 23, 

1991. CEFZIL is indicated for the 

treatment of patients with mild to 

moderate infections caused by 

susceptible strains of the designated 

microorganisms in the conditions listed 

below: 

• Upper respiratory tract: Pharyngitis/ 

tonsillitis caused by Streptococcus 

pyogenes; otitis media caused by 

Streptococcus pneumoniae, 

Haemophilus influenzae (including blactamase-producing strains), and 

Moraxella (Branhamella) catarrhalis 

(including b-lactamase-producing 

strains); and acute sinusitis caused by 

Streptococcus pneumoniae, 

Haemophilus influenzae (including blactamase-producing strains), and 

Moraxella (Branhamella) catarrhalis 

(including b-lactamase-producing 

strains); 

• Lower respiratory tract: Acute 

bacterial exacerbation of chronic 

bronchitis caused by Streptococcus 

pneumoniae, Haemophilus influenzae 

(including b-lactamase-producing 

strains), and Moraxella (Branhamella) 

catarrhalis (including b-lactamaseproducing strains); and 

• Skin and skin structure: 

Uncomplicated skin and skin-structure 

infections caused by Staphylococcus 

aureus (including penicillinaseproducing strains) and Streptococcus 

pyogenes. Abscesses usually require 

surgical drainage. 

In a letter dated September 7, 2010, 

Bristol-Myers Squibb 1 notified FDA that 

CEFZIL (cefprozil) tablets, 250 mg and 

500 mg and CEFZIL (cefprozil) for oral 

suspension, 125 mg/5 mL and 250 mg/ 

5 mL, were discontinued from sale, and 

FDA moved the drug products to the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. Later, 

Corden Pharma Latina S.p.A. notified 

the Agency in writing that these drug 

products were no longer marketed and 

requested that the approval of the 

applications be withdrawn. In the 

Federal Register of June 21, 2017 (82 FR 

28322 at 28326), the Agency issued a 

notice withdrawing approval of the 

applications, effective July 21, 2017. 

After reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that CEFZIL (cefprozil) 

tablets, 250 mg and 500 mg, and CEFZIL 

(cefprozil) for oral suspension, 125 mg/ 

5 mL and 250 mg/5 mL, were not 

withdrawn from sale for reasons of 

safety or effectiveness. 

We note that CEFZIL (cefprozil) 

tablets, 250 mg and 500 mg, and CEFZIL 

(cefprozil) for oral suspension, 125 mg/ 

5 mL and 250 mg/5 mL, previously were 

approved with an indication for 

secondary bacterial infection of acute 

bronchitis (SBIAB). On October 3, 2016, 

FDA sent Corden Pharma Latina S.p.A. 

a Prior Approval Supplement Request 

letter seeking removal of the SBIAB 

indication from the labeling of these 

drug products. In response, on October 

28, 2016, Corden Pharma Latina S.p.A. 

submitted supplements proposing to 

remove the indication. On November 

22, 2016, FDA approved these 

supplements and the indication was 


daltland on DSKBBV9HB2PROD with NOTICES