[Federal Register Volume 88, Number 191 (Wednesday, October 4, 2023)]
[Notices]
[Pages 68623-68624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21990]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-P-2656]


Determination That ULTRAM (Tramadol Hydrochloride) Tablets, 50 
Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or 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, the Agency, or we) has 
determined that ULTRAM (tramadol hydrochloride) Tablets, 50 milligrams 
(mg), was not withdrawn from sale for reasons of safety or 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.

[[Page 68624]]


FOR FURTHER INFORMATION CONTACT: Joan Dailey, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-6357, [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.
    ULTRAM (tramadol hydrochloride) Tablets, 50 mg, is the subject of 
NDA 020281, held by Janssen Pharmaceuticals, Inc., and initially 
approved on March 3, 1995. ULTRAM is indicated for the management of 
pain severe enough to require an opioid analgesic and for which 
alternative treatments are inadequate.
    ULTRAM (tramadol hydrochloride) Tablets, 50 mg, is currently listed 
in the ``Discontinued Drug Product List'' section of the Orange Book.
    Hyman, Phelps & McNamara, P.C. submitted a citizen petition dated 
June 28, 2023 (Docket No. FDA-2023-P-2656), under 21 CFR 10.30, 
requesting that the Agency determine whether ULTRAM (tramadol 
hydrochloride) Tablets, 50 mg, was withdrawn from sale for reasons of 
safety or effectiveness. The citizen petition noted that FDA has 
already determined that the 100 mg tablet strength of the same drug was 
not discontinued for reasons of safety or effectiveness (see the 
Federal Register of April 27, 2022 (87 FR 25028)).
    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 ULTRAM (tramadol hydrochloride) Tablets, 50 
mg, was not withdrawn for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
ULTRAM (tramadol hydrochloride) Tablets, 50 mg, was withdrawn for 
reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of ULTRAM (tramadol 
hydrochloride) Tablets, 50 mg, 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 ULTRAM (tramadol 
hydrochloride) Tablets, 50 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: September 29, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-21990 Filed 10-3-23; 8:45 am]
BILLING CODE 4164-01-P