[Federal Register Volume 89, Number 191 (Wednesday, October 2, 2024)]
[Notices]
[Pages 80258-80259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22572]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-P-2314]


Determination That AUGMENTIN XR (Amoxicillin; Clavulanate 
Potassium) Extended-Release Tablets, 1 Gram; Equivalent to 62.5 
Milligram Base, Was Not Withdrawn From Sale for Reasons of Safety or 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 AUGMENTIN XR (amoxicillin; clavulanate potassium) 
Extended-Release Tablets, 1 gram (gm); equivalent to (EQ) 62.5 
milligram (mg) base, was not withdrawn from sale for reasons of safety 
or effectiveness. This determination will allow FDA to approve 
abbreviated new drug applications (ANDAs) for AUGMENTIN XR 
(amoxicillin; clavulanate potassium) Extended-Release Tablets, 1 gm; EQ 
62.5 mg base, if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Awo Archampong-Gray, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6243, Silver Spring, MD 20993-0002, 301-
796-0110, <a href="/cdn-cgi/l/email-protection#68291f0746291a0b0009051807060f452f1a0911280e0c094600001b460f071e"><span class="__cf_email__" data-cfemail="dd9caab2f39cafbeb5bcb0adb2b3baf09aafbca49dbbb9bcf3b5b5aef3bab2ab">[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.
    AUGMENTIN (amoxicillin; clavulanate potassium) Extended-Release 
Tablets, 1 gm; EQ 62.5 mg base, is the subject of NDA 050785, held by 
US Antibiotics, LLC, and initially approved on September 25, 2002. 
AUGMENTIN XR is indicated for treatment of adults and pediatric 
patients with community-acquired pneumonia or acute bacterial sinusitis 
due to confirmed, or suspected beta-lactamase-producing pathogens 
(i.e., H. influenzae, M. catarrhalis, H. parainfluenzae, K. pneumoniae, 
or methicillin-susceptible S. aureus) and S. pneumoniae with reduced 
susceptibility to penicillin (i.e., penicillin minimum inhibitory 
concentrations EQ 2 microgram/milliliter).
    AUGMENTIN XR (amoxicillin; clavulanate potassium) Extended-Release 
Tablets, 1 gm; EQ 62.5 mg base, is currently listed in the 
``Discontinued Drug Product List'' section of the Orange Book.
    Aurobindo Pharma, USA, Inc. submitted a citizen petition dated May 
9, 2024 (Docket No. FDA-2024-P-2314), under 21 CFR 10.30, requesting 
that the Agency determine whether AUGMENTIN XR (amoxicillin; 
clavulanate potassium) Extended-Release Tablets, 1 gm; EQ 62.5 mg base, 
was withdrawn from sale for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records 
and based on the information we have at this time, FDA has determined 
under Sec.  314.161 that AUGMENTIN XR (amoxicillin; clavulanate 
potassium) Extended-Release Tablets, 1 gm; EQ 62.5 mg base, was not 
withdrawn for reasons of safety or effectiveness. The petitioner has 
identified no data or other information suggesting that AUGMENTIN XR 
(amoxicillin; clavulanate potassium) Extended-Release Tablets, 1 gm; EQ 
62.5 mg base, was withdrawn for reasons of safety or effectiveness. We 
have carefully reviewed our files for records concerning the withdrawal 
of AUGMENTIN XR (amoxicillin; clavulanate potassium) Extended-Release 
Tablets, 1 gm; EQ 62.5 mg base, from sale. We have also independently 
evaluated relevant literature and data for possible postmarketing 
adverse events. We have found no information that would indicate that 
this drug product was withdrawn from sale for reasons of safety or 
effectiveness.
    Accordingly, the Agency will continue to list AUGMENTIN XR 
(amoxicillin; clavulanate potassium) Extended-Release Tablets, 1 gm; EQ 
62.5 mg base, in the ``Discontinued Drug Product List'' section of the 
Orange Book. The ``Discontinued Drug Product List'' delineates, among 
other items, drug products that have been

[[Page 80259]]

discontinued from marketing for reasons other than safety or 
effectiveness. 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: September 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-22572 Filed 10-1-24; 8:45 am]
BILLING CODE 4164-01-P


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