[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40587-40588]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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375 Milligrams and 500 Milligrams Were Not Withdrawn From Sale for 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Bacterial Infections of Acute Bronchitis, Which Was Withdrawn From Sale 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milligrams (mg) and 500 mg were not withdrawn from sale for reasons of 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withdrawn for reasons of safety or effectiveness.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, 
[email protected].

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:
     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.
     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.
     Pharyngitis and tonsillitis due to Streptococcus pyogenes.
     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