83 FR 45940 - 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and 500 Milligrams, and for Oral Suspension, 125 Milligrams/5 Milliliters and 250 Milligrams/5 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 176 (September 11, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 176 (September 11, 2018)
| Page Range | 45940-45941 | |
| FR Document | 2018-19663 |
[Federal Register Volume 83, Number 176 (Tuesday, September 11, 2018)] [Notices] [Pages 45940-45941] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19663] ----------------------------------------------------------------------- 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and 500 Milligrams, and for Oral Suspension, 125 Milligrams/5 Milliliters and 250 Milligrams/5 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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(mg) and 500 mg and CEFZIL (cefprozil) for oral suspension, 125 mg/5 milliliters (mL) and 250 mg/5 mL were not withdrawn from sale for reasons of safety or effectiveness.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 (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. Under Sec. 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 [beta]-lactamase- producing strains), and Moraxella (Branhamella) catarrhalis (including [beta]-lactamase-producing strains); and acute sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including [beta]- lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including [beta]-lactamase-producing strains); Lower respiratory tract: Acute bacterial exacerbation of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including [beta]-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including [beta]-lactamase- producing strains); and Skin and skin structure: Uncomplicated skin and skin- structure infections caused by Staphylococcus aureus (including penicillinase-producing 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. --------------------------------------------------------------------------- \1\ On May 26, 2011, Bristol-Myers Squibb transferred ownership of NDA 050664 and NDA 050665 to Corden Pharma Latina S.p.A. --------------------------------------------------------------------------- After reviewing Agency records and based on the information we have at this time, FDA has determined under Sec. 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 [[Page 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
![45940 Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices
attribute this adjustment to an increase The 1984 amendments include what Streptococcus pneumoniae,
in the number of entities submitting is now section 505(j)(7) of the Federal Haemophilus influenzae (including b-
tobacco user fee information to FDA. Food, Drug, and Cosmetic Act (FD&C lactamase-producing strains), and
Dated: September 4, 2018. Act) (21 U.S.C. 355(j)(7)), which Moraxella (Branhamella) catarrhalis
Leslie Kux,
requires FDA to publish a list of all (including b-lactamase-producing
approved drugs. FDA publishes this list strains);
Associate Commissioner for Policy.
as part of the ‘‘Approved Drug Products • Lower respiratory tract: Acute
[FR Doc. 2018–19664 Filed 9–10–18; 8:45 am] With Therapeutic Equivalence bacterial exacerbation of chronic
BILLING CODE 4164–01–P Evaluations,’’ which is known generally bronchitis caused by Streptococcus
as the ‘‘Orange Book.’’ Under FDA pneumoniae, Haemophilus influenzae
regulations, drugs are removed from the (including b-lactamase-producing
DEPARTMENT OF HEALTH AND list if the Agency withdraws or strains), and Moraxella (Branhamella)
HUMAN SERVICES suspends approval of the drug’s NDA or catarrhalis (including b-lactamase-
ANDA for reasons of safety or producing strains); and
Food and Drug Administration
effectiveness or if FDA determines that • Skin and skin structure:
[Docket No. FDA–2018–N–3262] the listed drug was withdrawn from sale Uncomplicated skin and skin-structure
for reasons of safety or effectiveness (21 infections caused by Staphylococcus
Determination That CEFZIL (Cefprozil) CFR 314.162). aureus (including penicillinase-
Tablets, 250 Milligrams and 500 A person may petition the Agency to producing strains) and Streptococcus
Milligrams, and for Oral Suspension, determine, or the Agency may pyogenes. Abscesses usually require
125 Milligrams/5 Milliliters and 250 determine on its own initiative, whether surgical drainage.
Milligrams/5 Milliliters, Were Not a listed drug was withdrawn from sale In a letter dated September 7, 2010,
Withdrawn From Sale for Reasons of for reasons of safety or effectiveness. Bristol-Myers Squibb 1 notified FDA that
Safety or Effectiveness This determination may be made at any CEFZIL (cefprozil) tablets, 250 mg and
AGENCY: Food and Drug Administration, time after the drug has been withdrawn 500 mg and CEFZIL (cefprozil) for oral
HHS. from sale, but must be made prior to suspension, 125 mg/5 mL and 250 mg/
approving an ANDA that refers to the 5 mL, were discontinued from sale, and
ACTION: Notice. listed drug (§ 314.161 (21 CFR 314.161)). FDA moved the drug products to the
SUMMARY: The Food and Drug FDA may not approve an ANDA that ‘‘Discontinued Drug Product List’’
Administration (FDA or Agency) has does not refer to a listed drug. section of the Orange Book. Later,
determined that CEFZIL (cefprozil) Under § 314.161(a)(2), the Agency Corden Pharma Latina S.p.A. notified
tablets, 250 milligrams (mg) and 500 mg must also determine whether a listed the Agency in writing that these drug
and CEFZIL (cefprozil) for oral drug was withdrawn from sale for products were no longer marketed and
suspension, 125 mg/5 milliliters (mL) reasons of safety or effectiveness if requested that the approval of the
and 250 mg/5 mL were not withdrawn ANDAs that referred to the listed drug applications be withdrawn. In the
from sale for reasons of safety or have already been approved prior to its Federal Register of June 21, 2017 (82 FR
effectiveness. This determination will market withdrawal. If the Agency 28322 at 28326), the Agency issued a
allow FDA to continue to approve determines that a listed drug was notice withdrawing approval of the
abbreviated new drug applications withdrawn from sale for reasons of applications, effective July 21, 2017.
safety or effectiveness, and there are After reviewing Agency records and
(ANDAs) that refer to these drugs as
approved ANDAs that reference that based on the information we have at this
long as they meet relevant legal and
listed drug, FDA will initiate a time, FDA has determined under
regulatory requirements.
proceeding to determine whether the § 314.161 that CEFZIL (cefprozil)
FOR FURTHER INFORMATION CONTACT: suspension of the ANDAs is also
Diana J. Pomeranz, Center for Drug tablets, 250 mg and 500 mg, and CEFZIL
required (21 CFR 314.153(b)). (cefprozil) for oral suspension, 125 mg/
Evaluation and Research, Food and CEFZIL (cefprozil) tablets, 250 mg and
Drug Administration, 10903 New 5 mL and 250 mg/5 mL, were not
500 mg, are the subject of NDA 050664 withdrawn from sale for reasons of
Hampshire Ave., Bldg. 51, Rm. 6288, held by Corden Pharma Latina S.p.A.,
Silver Spring, MD 20993–0002, 240– safety or effectiveness.
and initially approved on December 23, We note that CEFZIL (cefprozil)
402–4654. 1991. CEFZIL (cefprozil) for oral tablets, 250 mg and 500 mg, and CEFZIL
SUPPLEMENTARY INFORMATION: In 1984, suspension, 125 mg/5 mL and 250 mg/ (cefprozil) for oral suspension, 125 mg/
Congress enacted the Drug Price 5 mL, is the subject of NDA 050665 held 5 mL and 250 mg/5 mL, previously were
Competition and Patent Term by Corden Pharma Latina S.p.A., and approved with an indication for
Restoration Act of 1984 (Pub. L. 98–417) initially approved on December 23, secondary bacterial infection of acute
(the 1984 amendments), which 1991. CEFZIL is indicated for the bronchitis (SBIAB). On October 3, 2016,
authorized the approval of duplicate treatment of patients with mild to FDA sent Corden Pharma Latina S.p.A.
versions of drug products under an moderate infections caused by a Prior Approval Supplement Request
ANDA procedure. ANDA applicants susceptible strains of the designated letter seeking removal of the SBIAB
must, with certain exceptions, show that microorganisms in the conditions listed indication from the labeling of these
the drug for which they are seeking below: drug products. In response, on October
approval contains the same active • Upper respiratory tract: Pharyngitis/ 28, 2016, Corden Pharma Latina S.p.A.
ingredient in the same strength and tonsillitis caused by Streptococcus submitted supplements proposing to
daltland on DSKBBV9HB2PROD with NOTICES
dosage form as the ‘‘listed drug,’’ which pyogenes; otitis media caused by remove the indication. On November
is a version of the drug that was Streptococcus pneumoniae, 22, 2016, FDA approved these
previously approved. ANDA applicants Haemophilus influenzae (including b- supplements and the indication was
do not have to repeat the extensive lactamase-producing strains), and
clinical testing otherwise necessary to Moraxella (Branhamella) catarrhalis 1 On May 26, 2011, Bristol-Myers Squibb
gain approval of a new drug application (including b-lactamase-producing transferred ownership of NDA 050664 and NDA
(NDA). strains); and acute sinusitis caused by 050665 to Corden Pharma Latina S.p.A.
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![Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices 45941
removed. The ANDA applicants Drug Products Advisory Committee. The as a manufacturing process. Please note
referencing these NDAs subsequently general function of the committee is to that if you include your name, contact
followed suit and submitted provide advice and recommendations to information, or other information that
supplements proposing to remove the FDA on regulatory issues. The meeting identifies you in the body of your
SBIAB indication from their labeling. will be open to the public. FDA is comments, that information will be
The Agency approved these establishing a docket for public posted on https://www.regulations.gov.
supplements. comment on this document. • If you want to submit a comment
Further, based on a review of relevant DATES: The meeting will be held on with confidential information that you
information, FDA concluded that the October 11, 2018, from 8 a.m. to 5 p.m. do not wish to be made available to the
SBIAB indication is not appropriate public, submit the comment as a
ADDRESSES: FDA White Oak Campus,
because most cases of SBIAB are written/paper submission and in the
10903 New Hampshire Ave., Bldg. 31,
considered to be viral or non-infectious. manner detailed (see ‘‘Written/Paper
Conference Center, the Great Room (Rm. Submissions’’ and ‘‘Instructions’’).
As an antibacterial drug, CEFZIL 1503), Silver Spring, MD 20993–0002.
(cefprozil) is not considered to be Answers to commonly asked questions Written/Paper Submissions
effective to treat SBIAB. Such use of including information regarding special
CEFZIL (cefprozil) would likely result Submit written/paper submissions as
accommodations due to a disability, follows:
in inappropriate antibacterial drug use. visitor parking, and transportation may • Mail/Hand delivery/Courier (for
Accordingly, the risk benefit balance for be accessed at: https://www.fda.gov/ written/paper submissions): Dockets
the treatment of SBIAB with CEFZIL AdvisoryCommittees/ Management Staff (HFA–305), Food and
(cefprozil) is unfavorable and does not AboutAdvisoryCommittees/ Drug Administration, 5630 Fishers
support approval of these products (or ucm408555.htm. Lane, Rm. 1061, Rockville, MD 20852.
ANDAs referencing them) for this FDA is establishing a docket for • For written/paper comments
indication. public comment on this meeting. The submitted to the Dockets Management
The Agency will continue to list docket number is FDA–2018–N–3276. Staff, FDA will post your comment, as
CEFZIL (cefprozil) tablets, 250 mg and The docket will close on October 10, well as any attachments, except for
500 mg, and CEFZIL (cefprozil) for oral 2018. Submit either electronic or information submitted, marked and
suspension, 125 mg/5 mL and 250 mg/ written comments on this public identified, as confidential, if submitted
5 mL, in the ‘‘Discontinued Drug meeting by October 10, 2018. Please as detailed in ‘‘Instructions.’’
Product List’’ section of the Orange note that late, untimely filed comments Instructions: All submissions received
Book. FDA will continue to accept and, will not be considered. Electronic must include the Docket No. FDA–
where appropriate, approve ANDAs that comments must be submitted on or 2018–N–3276 for ‘‘Anesthetic and
refer to these drug products, but does before October 10, 2018. The https:// Analgesic Drug Products Advisory
not intend to do so if they propose to www.regulations.gov electronic filing Committee; Notice of Meeting;
include the SBIAB indication (see, e.g., system will accept comments until Establishment of a Public Docket;
section 505(j)(2)(A)(v) and (j)(4)G) of the midnight Eastern Time at the end of Request for Comments.’’ Received
FD&C Act and 21 CFR 314.94(a)(8)(iv) October 10, 2018. Comments received comments, those filed in a timely
and 314.127(a)(7)). If FDA determines by mail/hand delivery/courier (for manner (see ADDRESSES), will be placed
that labeling for this drug product written/paper submissions) will be in the docket and, except for those
should be revised, the Agency will considered timely if they are submitted as ‘‘Confidential
advise ANDA applicants to submit such postmarked or the delivery service Submissions,’’ publicly viewable at
labeling. acceptance receipt is on or before that https://www.regulations.gov or at the
Dated: September 4, 2018. date. Dockets Management Staff between 9
Leslie Kux, Comments received on or before a.m. and 4 p.m., Monday through
Associate Commissioner for Policy. October 3, 2018, will be provided to the Friday.
[FR Doc. 2018–19663 Filed 9–10–18; 8:45 am] committee. Comments received after • Confidential Submissions—To
that date will be taken into submit a comment with confidential
BILLING CODE 4164–01–P
consideration by FDA. information that you do not wish to be
You may submit comments as made publicly available, submit your
DEPARTMENT OF HEALTH AND follows: comments only as a written/paper
HUMAN SERVICES submission. You should submit two
Electronic Submissions copies total. One copy will include the
Food and Drug Administration Submit electronic comments in the information you claim to be confidential
following way: with a heading or cover note that states
[Docket No. FDA–2018–N–3276] • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ FDA
Anesthetic and Analgesic Drug
instructions for submitting comments. will review this copy, including the
Products Advisory Committee; Notice
Comments submitted electronically, claimed confidential information, in its
of Meeting; Establishment of a Public
including attachments, to https:// consideration of comments. The second
Docket; Request for Comments
www.regulations.gov will be posted to copy, which will have the claimed
AGENCY: Food and Drug Administration, the docket unchanged. Because your confidential information redacted/
HHS. comment will be made public, you are blacked out, will be available for public
daltland on DSKBBV9HB2PROD with NOTICES
ACTION: Notice; establishment of a solely responsible for ensuring that your viewing and posted on https://
public docket; request for comments. comment does not include any www.regulations.gov. Submit both
confidential information that you or a copies to the Dockets Management Staff.
SUMMARY: The Food and Drug third party may not wish to be posted, If you do not wish your name and
Administration (FDA) announces a such as medical information, your or contact information be made publicly
forthcoming public advisory committee anyone else’s Social Security number, or available, you can provide this
meeting of the Anesthetic and Analgesic confidential business information, such information on the cover sheet and not
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Document Created: 2018-09-11 01:02:52
Document Modified: 2018-09-11 01:02:52
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| FR Citation | 83 FR 45940 |
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