2024-22572. 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XR (Amoxicillin; Clavulanate Potassium) Extended-Release Tablets, 1 Gram; Equivalent to 62.5 Milligram Base, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Document Headings

Document headings vary by document type but may contain the following:

1. the agency or agencies that issued and signed a document
2. the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to
3. the agency docket number / agency internal file number
4. the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions

See the Document Drafting Handbook for more details.

Department of Health and Human Services

Food and Drug Administration

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

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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clavulanate potassium) Extended-Release Tablets, 1 gram (gm); equivalent to (EQ) 62.5 milligram (mg) base, was not withdrawn from sale for reasons of safety or effectiveness.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, [e-mail].

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 (§ 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 § 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 ( print 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.