[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Milligram Base, Was Not Withdrawn From Sale for Reasons of Safety or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milligram (mg) base, was not withdrawn from sale for reasons of safety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, [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.
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