[Federal Register Volume 87, Number 139 (Thursday, July 21, 2022)]
[Notices]
[Page 43533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-15594]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-P-1248]


Determination That XYLOCAINE (Lidocaine Hydrochloride) Topical 
Solution 4%, Was Not Withdrawn From Sale for Reasons of Safety or 
Effectiveness

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) has 
determined that XYLOCAINE (lidocaine hydrochloride), Topical Solution 
4%, was not withdrawn from sale for reasons of safety or effectiveness.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: David Faranda, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6258, Silver Spring, MD 20993-0002, 301-
796-8767, [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 FDA's approval of 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.
    XYLOCAINE (lidocaine hydrochloride) Topical Solution 4%, is the 
subject of NDA 010417, held by Fresenius Kabi USA, LLC, and initially 
approved on May 7, 1959. XYLOCAINE is indicated for the production of 
topical anesthesia of the mucous membranes of the respiratory tract or 
the genito-urinary tract.
    In a letter dated January 29, 2018, Fresenius Kabi USA, LLC, 
requested that FDA withdraw approval of NDA 010417 for XYLOCAINE 
(lidocaine hydrochloride). In the Federal Register of October 29, 2018 
(83 FR 54355 at 54356), FDA announced that it was withdrawing approval 
of NDA 010417 as of November 28, 2018. This product is identified as 
discontinued in the Orange Book.
    Lyne Laboratories, Inc., submitted a citizen petition dated 
December 2, 2021 (Docket No. FDA-2021-P-1248), under 21 CFR 10.30, 
requesting that the Agency determine whether XYLOCAINE (lidocaine 
hydrochloride) Topical Solution 4%, 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 XYLOCAINE (lidocaine hydrochloride) Topical 
Solution 4%, was not withdrawn for reasons of safety or effectiveness. 
The petitioner has identified no data or other information suggesting 
that this drug product was withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of XYLOCAINE (lidocaine hydrochloride) 
Topical Solution 4 percent, 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 XYLOCAINE (lidocaine 
hydrochloride) Topical Solution 4%, 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: July 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15594 Filed 7-20-22; 8:45 am]
BILLING CODE 4164-01-P


