Notice2021-16050
Determination That CECLOR CD (Cefaclor Extended-Release Tablets) 375 Milligrams and 500 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, Except the Indication of Secondary Bacterial Infections of Acute Bronchitis, Which Was Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
July 28, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) has determined that CECLOR CD (cefaclor extended-release tablets) 375 milligrams (mg) and 500 mg were not withdrawn from sale for reasons of safety or effectiveness, except with respect to the indication of secondary bacterial infections of acute bronchitis (SBIAB) that was withdrawn for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to suspend approval of any abbreviated new drug application (ANDA) that refers to this drug product and has removed the indication for SBIAB. This determination also will allow FDA to continue to approve ANDAs that refer to these drug products as long as they meet relevant legal and regulatory requirements. However, the Agency will not accept or approve ANDAs for CECLOR CD (cefaclor extended-release tablets) 375 mg and 500 mg that include SBIAB as an indication.
Full Text
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<title>Federal Register, Volume 86 Issue 142 (Wednesday, July 28, 2021)</title>
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[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40587-40588]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-16050]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0649]
Determination That CECLOR CD (Cefaclor Extended-Release Tablets)
375 Milligrams and 500 Milligrams Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness, Except the Indication of Secondary
Bacterial Infections of Acute Bronchitis, Which Was Withdrawn From Sale
for Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) has
determined that CECLOR CD (cefaclor extended-release tablets) 375
milligrams (mg) and 500 mg were not withdrawn from sale for reasons of
safety or effectiveness, except with respect to the indication of
secondary bacterial infections of acute bronchitis (SBIAB) that was
withdrawn for reasons of safety or effectiveness. This determination
means that FDA will not begin procedures to suspend approval of any
abbreviated new drug application (ANDA) that refers to this drug
product and has removed the indication for SBIAB. This determination
also will allow FDA to continue to approve ANDAs that refer to these
drug products as long as they meet relevant legal and regulatory
requirements. However, the Agency will not accept or approve ANDAs for
CECLOR CD (cefaclor extended-release tablets) 375 mg and 500 mg that
include SBIAB as an indication.
FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363,
<a href="/cdn-cgi/l/email-protection#72210613110b5c39131c17321416135c1a1a015c151d04"><span class="__cf_email__" data-cfemail="2172554042580f6a404f44614745400f4949520f464e57">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) Has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and, with certain exceptions, labeling as the listed
drug, which is a version of the drug that was previously approved and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act 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 314.161(d)).
CECLOR CD (cefaclor extended-release tablets) 375 mg and 500 mg are
the subject of NDA 050673 held by Eli Lilly and Co., and initially
approved on June 28, 1996. CECLOR CD (cefaclor extended-release
tablets) is indicated for the treatment of patients with the following
mild to moderate infections when caused by susceptible strains of the
designated microorganisms:
<bullet> Acute bacterial exacerbations of chronic bronchitis due to
Haemophilus influenzae (non-[beta]-lactamase-producing strains only),
Moraxella catarrhalis (including [beta]-lactamase-producing strains) or
Streptococcus pneumoniae.
<bullet> Secondary bacterial infections of acute bronchitis due to
H. influenzae (non-[beta]-lactamase-producing strains only), M.
catarrhalis (including [beta]-lactamase-producing strains), or S.
pneumoniae.
<bullet> Pharyngitis and tonsillitis due to Streptococcus pyogenes.
<bullet> Uncomplicated skin and skin structure infections due to
Staphylococcus aureus (methicillin-susceptible).
On June 13, 2005, Eli Lilly and Co. submitted a request to the
Agency to withdraw approval of NDA 050673, CECLOR CD (cefaclor
extended-release tablets), 375 mg and 500 mg, under 21 CFR 314.150(c).
The Agency published a Federal Register notice on April 22, 2014,
withdrawing approval of NDA 050673, effective May 22, 2014.\1\
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\1\ See 79 FR 22501 (April 22, 2014).
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After reviewing Agency records and based on the information we have
at this time, FDA has determined under Sec. 314.161 that CECLOR CD
(cefaclor extended-release tablets), 375 mg and 500 mg, were not
withdrawn from sale for reasons of safety or effectiveness, except with
respect to the indication for SBIAB.
Based on a review of relevant information, FDA has concluded that
the SBIAB indication is not appropriate because most cases of SBIAB are
considered to be viral or noninfectious. As an antibacterial drug,
CECLOR CD (cefaclor extended-release tablets) is not considered to be
effective to treat SBIAB. Such use of CECLOR CD (cefaclor extended-
release tablets) would likely result in inappropriate antibacterial
drug use. Accordingly, for the treatment of SBIAB, the benefit-risk
profile of CECLOR CD (cefaclor extended-release tablets) is unfavorable
and does not support approval of these products (or ANDAs referencing
them) for this indication. For the remaining indications, the Agency
has determined that CECLOR CD (cefaclor extended-release tablets)
continues to have a favorable benefit-risk profile.
Accordingly, the Agency will continue to list CECLOR CD (cefaclor
extended-release tablets), 375 mg and 500 mg, in the ``Discontinued
Drug Product List'' section of the Orange Book. The approved ANDA has
[[Page 40588]]
removed the SBIAB indication from its labeling, consistent with this
decision. In addition, FDA will continue to accept and, where
appropriate, approve ANDAs that refer to CECLOR CD (cefaclor extended-
release tablets) as long as they meet relevant legal and regulatory
requirements, but FDA will not accept or approve ANDAs that refer to
this drug product and propose to include the SBIAB indication. If FDA
determines that labeling for this drug product should be revised to
meet current standards, the Agency will advise ANDA applicants to
submit such labeling.
Dated: July 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16050 Filed 7-27-21; 8:45 am]
BILLING CODE 4164-01-P
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