Determination That DUEXIS (Ibuprofen and Famotidine) Tablet, 800 Milligrams and 26.6 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 18945-18946 [2024-05578]

Download as PDF Federal Register / Vol. 89, No. 52 / Friday, March 15, 2024 / Notices experimental methods (i.e., phantom, ex vivo tissue, and/or in vivo tissue models), computational methods, and/ or clinical studies may be appropriate to assess thermal effects. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Evaluation of Thermal Effects of Medical Devices That Produce Tissue Heating and/or Cooling.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/medical-devices/ device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This guidance document is also available at https://www.regulations.gov or https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents. Persons unable to download an electronic copy of ‘‘Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling’’ may send an email request to CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number GUI00022002 and complete title to identify the guidance you are requesting. III. Paperwork Reduction Act of 1995 While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3521). The collections of information in the following table have been approved by OMB: 21 CFR part or guidance Topic 807, subpart E ........................................................................ 814, subparts A through E ..................................................... 814, subpart H ........................................................................ 812 .......................................................................................... 860, subpart D ........................................................................ ‘‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program’’. 800, 801, 809, and 830 .......................................................... Premarket notification ............................................................. Premarket approval ................................................................ Humanitarian Use Devices; Humanitarian Device Exemption Investigational Device Exemption .......................................... De Novo classification process .............................................. Q-submissions and Early Payor Feedback Request Programs for Medical Devices. Medical Device Labeling Regulations; Unique Device Identification. Dated: March 12, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–05584 Filed 3–14–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–P–0827] Determination That DUEXIS (Ibuprofen and Famotidine) Tablet, 800 Milligrams and 26.6 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that DUEXIS (ibuprofen and famotidine) tablet, 800 milligrams (mg) ibuprofen and 26.6 mg famotidine, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES II. Electronic Access VerDate Sep<11>2014 18:17 Mar 14, 2024 Jkt 262001 product as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Grace St. Vincent, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6215, Silver Spring, MD 20993–0002, 240– 402–9201, Grace.StVincent@ fda.hhs.gov. 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 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 18945 OMB control No. 0910–0120 0910–0231 0910–0332 0910–0078 0910–0844 0910–0756 0910–0485 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. DUEXIS (ibuprofen and famotidine) tablet, 800 mg and 26.6 mg, is the subject of NDA 022519, held by Horizon Medicines LLC, and initially approved on April 23, 2011. DUEXIS is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers in patients who are taking ibuprofen for those indications. In a letter dated August 10, 2023, Horizon Medicines LLC notified FDA E:\FR\FM\15MRN1.SGM 15MRN1 khammond on DSKJM1Z7X2PROD with NOTICES 18946 Federal Register / Vol. 89, No. 52 / Friday, March 15, 2024 / Notices that DUEXIS (ibuprofen and famotidine) tablet, 800 mg and 26.6 mg, was being discontinued, and FDA moved the drug product to the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Aurobindo Pharma USA, Inc., submitted a citizen petition dated February 14, 2024 (Docket No. FDA– 2024–P–0827), under 21 CFR 10.30, requesting that the Agency determine whether DUEXIS (ibuprofen and famotidine) tablet, 800 mg and 26.6 mg, 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 DUEXIS (ibuprofen and famotidine) tablet, 800 mg and 26.6 mg, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that DUEXIS (ibuprofen and famotidine) tablet, 800 mg and 26.6 mg, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of DUEXIS (ibuprofen and famotidine) tablet, 800 mg and 26.6 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that this drug product was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list DUEXIS (ibuprofen and famotidine) tablet, 800 mg and 26.6 mg, 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 discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. 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: March 12, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–05578 Filed 3–14–24; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 18:17 Mar 14, 2024 Jkt 262001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–P–4065] Determination That NUCYNTA (Tapentadol Hydrochloride) Solution, Equivalent 20 Milligrams Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that NUCYNTA (tapentadol hydrochloride) solution, equivalent (eq) 20 milligrams (mg) base/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for tapentadol hydrochloride solution, eq 20 mg base/ mL, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Kaetochi Okemgbo, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6624, Silver Spring, MD 20993–0002, 301– 796–1546, Kaetochi.Okemgbo@ fda.hhs.gov. SUMMARY: 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 SUPPLEMENTARY INFORMATION: PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness § 314.162 (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. NUCYNTA (tapentadol hydrochloride) solution, eq 20 mg base/ mL, is the subject of NDA 203794, held by Collegium Pharmaceutical, Inc., and initially approved on October 15, 2012. NUCYNTA is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 16 kilograms. Collegium Pharmaceutical, Inc. has never marketed NUCYNTA (tapentadol hydrochloride) solution, eq 20 mg base/ mL. In previous instances (see, e.g., 72 FR 9763, March 5, 2007; 61 FR 25497, May 21, 1996, the Agency has determined that, for purposes of §§ 314.161 and 314.162, never marketing an approved drug product is equivalent to withdrawing the drug from sale. Novitium Pharma, LLC submitted a citizen petition dated September 19, 2023 (Docket No. FDA–2023–P–4065), under 21 CFR 10.30, requesting that the Agency determine whether NUCYNTA (tapentadol hydrochloride) solution, eq 20 mg base/mL, 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 NUCYNTA (tapentadol hydrochloride) solution, eq 20 mg base/ mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that NUCYNTA (tapentadol hydrochloride) solution, eq 20 mg base/mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of NUCYNTA (tapentadol hydrochloride) solution, eq 20 mg base/mL, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and E:\FR\FM\15MRN1.SGM 15MRN1

Agencies

[Federal Register Volume 89, Number 52 (Friday, March 15, 2024)]
[Notices]
[Pages 18945-18946]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05578]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-P-0827]


Determination That DUEXIS (Ibuprofen and Famotidine) Tablet, 800 
Milligrams and 26.6 Milligrams, Was Not Withdrawn From Sale for Reasons 
of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) has 
determined that DUEXIS (ibuprofen and famotidine) tablet, 800 
milligrams (mg) ibuprofen and 26.6 mg famotidine, was not withdrawn 
from sale for reasons of safety or effectiveness. This determination 
means that FDA will not begin procedures to withdraw approval of 
abbreviated new drug applications (ANDAs) that refer to this drug 
product, and it will allow FDA to continue to approve ANDAs that refer 
to the product as long as they meet relevant legal and regulatory 
requirements.

FOR FURTHER INFORMATION CONTACT: Grace St. Vincent, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6215, Silver Spring, MD 20993-0002, 240-
402-9201, [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.
    DUEXIS (ibuprofen and famotidine) tablet, 800 mg and 26.6 mg, is 
the subject of NDA 022519, held by Horizon Medicines LLC, and initially 
approved on April 23, 2011. DUEXIS is indicated for the relief of signs 
and symptoms of rheumatoid arthritis and osteoarthritis and to decrease 
the risk of developing upper gastrointestinal ulcers in patients who 
are taking ibuprofen for those indications.
    In a letter dated August 10, 2023, Horizon Medicines LLC notified 
FDA

[[Page 18946]]

that DUEXIS (ibuprofen and famotidine) tablet, 800 mg and 26.6 mg, was 
being discontinued, and FDA moved the drug product to the 
``Discontinued Drug Product List'' section of the Orange Book.
    Aurobindo Pharma USA, Inc., submitted a citizen petition dated 
February 14, 2024 (Docket No. FDA-2024-P-0827), under 21 CFR 10.30, 
requesting that the Agency determine whether DUEXIS (ibuprofen and 
famotidine) tablet, 800 mg and 26.6 mg, 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 DUEXIS (ibuprofen and famotidine) tablet, 800 
mg and 26.6 mg, was not withdrawn for reasons of safety or 
effectiveness. The petitioner has identified no data or other 
information suggesting that DUEXIS (ibuprofen and famotidine) tablet, 
800 mg and 26.6 mg, was withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of DUEXIS (ibuprofen and famotidine) tablet, 
800 mg and 26.6 mg, from sale. We have also independently evaluated 
relevant literature and data for possible postmarketing adverse events. 
We have reviewed the available evidence and determined that this drug 
product was not withdrawn from sale for reasons of safety or 
effectiveness.
    Accordingly, the Agency will continue to list DUEXIS (ibuprofen and 
famotidine) tablet, 800 mg and 26.6 mg, 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 discontinued from marketing for reasons other than safety or 
effectiveness. FDA will not begin procedures to withdraw approval of 
approved ANDAs that refer to this drug product. Additional ANDAs for 
this drug product may also be approved by the Agency as long as they 
meet all other legal and regulatory requirements for the approval of 
ANDAs. 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: March 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05578 Filed 3-14-24; 8:45 am]
BILLING CODE 4164-01-P

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