Notice2022-15594
Determination That XYLOCAINE (Lidocaine Hydrochloride) Topical Solution 4%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
July 21, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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(FDA, Agency, or we) has determined that XYLOCAINE (lidocaine hydrochloride), Topical Solution 4%, was not withdrawn from sale for reasons of safety or effectiveness.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.
Full Text
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<title>Federal Register, Volume 87 Issue 139 (Thursday, July 21, 2022)</title>
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[Federal Register Volume 87, Number 139 (Thursday, July 21, 2022)]
[Notices]
[Page 43533]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Solution 4%, Was Not Withdrawn From Sale for Reasons of Safety or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4%, was not withdrawn from sale for reasons of safety or effectiveness.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, <a href="/cdn-cgi/l/email-protection#6e2a0f18070a40280f1c0f000a0f2e080a0f4006061d40090118"><span class="__cf_email__" data-cfemail="6b2f0a1d020f452d0a190a050f0a2b0d0f0a45030318450c041d">[email protected]</span></a>.
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
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