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Withdrawn From Sale for Reasons of 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and 250 mg/5 mL were not withdrawn 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
Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices 45941 

removed. The ANDA applicants 

referencing these NDAs subsequently 

followed suit and submitted 

supplements proposing to remove the 

SBIAB indication from their labeling. 

The Agency approved these 

supplements. 

Further, based on a review of relevant 

information, FDA concluded that the 

SBIAB indication is not appropriate 

because most cases of SBIAB are 

considered to be viral or non-infectious. 

As an antibacterial drug, CEFZIL 

(cefprozil) is not considered to be 

effective to treat SBIAB. Such use of 

CEFZIL (cefprozil) would likely result 

in inappropriate antibacterial drug use. 

Accordingly, the risk benefit balance for 

the treatment of SBIAB with CEFZIL 

(cefprozil) is unfavorable and does not 

support approval of these products (or 

ANDAs referencing them) for this 

indication. 

The Agency will continue to list 

CEFZIL (cefprozil) tablets, 250 mg and 

500 mg, and CEFZIL (cefprozil) for oral 

suspension, 125 mg/5 mL and 250 mg/ 

5 mL, in the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. FDA will continue to accept and, 

where appropriate, approve ANDAs that 

refer to these drug products, but does 

not intend to do so if they propose to 

include the SBIAB indication (see, e.g., 

section 505(j)(2)(A)(v) and (j)(4)G) of the 

FD&C Act and 21 CFR 314.94(a)(8)(iv) 

and 314.127(a)(7)). If FDA determines 

that labeling for this drug product 

should be revised, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: September 4, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19663 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–3276] 

Anesthetic and Analgesic Drug 

Products Advisory Committee; Notice 

of Meeting; Establishment of a Public 

Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Anesthetic and Analgesic 

Drug Products Advisory Committee. The 

general function of the committee is to 

provide advice and recommendations to 

FDA on regulatory issues. The meeting 

will be open to the public. FDA is 

establishing a docket for public 

comment on this document. 

DATES: The meeting will be held on 

October 11, 2018, from 8 a.m. to 5 p.m. 

ADDRESSES: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31, 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

Answers to commonly asked questions 

including information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2018–N–3276. 

The docket will close on October 10, 

2018. Submit either electronic or 

written comments on this public 

meeting by October 10, 2018. Please 

note that late, untimely filed comments 

will not be considered. Electronic 

comments must be submitted on or 

before October 10, 2018. The https://

www.regulations.gov electronic filing 

system will accept comments until 

midnight Eastern Time at the end of 

October 10, 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. 

Comments received on or before 

October 3, 2018, will be provided to the 

committee. Comments received after 

that date will be taken into 

consideration by FDA. 

You may submit comments as 

follows: 

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–3276 for ‘‘Anesthetic and 

Analgesic Drug Products Advisory 

Committee; Notice of Meeting; 

Establishment of a Public 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 


daltland on DSKBBV9HB2PROD with NOTICES