Notice2022-20520
Determination That Prescription NIX (Permethrin) 1% Topical Creme Rinse Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
September 22, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) has determined that prescription NIX (permethrin) 1% topical creme rinse was not withdrawn from sale for reasons of safety or effectiveness. However, because NIX (permethrin) 1% topical creme rinse has been approved for nonprescription use, NIX and any generic product referencing prescription NIX would be misbranded under FDA regulations if marketed with the "Rx only" symbol. Moreover, FDA will not approve abbreviated new drug applications (ANDAs) referencing prescription NIX (permethrin) 1% topical creme rinse.
Full Text
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<title>Federal Register, Volume 87 Issue 183 (Thursday, September 22, 2022)</title>
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[Federal Register Volume 87, Number 183 (Thursday, September 22, 2022)]
[Notices]
[Pages 57907-57908]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-20520]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-P-3232]
Determination That Prescription NIX (Permethrin) 1% Topical Creme
Rinse Was Not Withdrawn From Sale for Reasons of Safety or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, Agency, or we) has
determined that prescription NIX (permethrin) 1% topical creme rinse
was not withdrawn from sale for reasons of safety or effectiveness.
However, because NIX (permethrin) 1% topical creme rinse has been
approved for nonprescription use, NIX and any generic product
referencing prescription NIX would be misbranded under FDA regulations
if marketed with the ``Rx only'' symbol. Moreover, FDA will not approve
abbreviated new drug applications (ANDAs) referencing prescription NIX
(permethrin) 1% topical creme rinse.
FOR FURTHER INFORMATION CONTACT: Linda Jong, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6288, Silver Spring, MD 20993-0002, 301-796-3977,
<a href="/cdn-cgi/l/email-protection#92defbfcf6f3bcd8fdfcf5d2f4f6f3bcfafae1bcf5fde4"><span class="__cf_email__" data-cfemail="7a3613141e1b543015141d3a1c1e1b54121209541d150c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
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.
Prescription NIX (permethrin) 1% topical creme rinse (Prescription
NIX) is the subject of NDA 019435, held by GlaxoSmithKline, and
initially approved on March 31, 1986. Prescription NIX is indicated for
the treatment of head lice.
On May 2, 1990, FDA approved a second NDA (NDA 019918) submitted by
GlaxoSmithKline, removing its NIX (permethrin) 1% topical creme rinse
for the treatment of head lice from the prescription dispensing
requirements of section 503(b) of the FD&C Act (21 U.S.C. 353(b)). When
it submitted NDA 019918, GlaxoSmithKline stated that it would no longer
market the prescription product. GlaxoSmithKline later informed FDA
that it had discontinued marketing of the prescription product on June
14, 1990. NDA 019918 is now held by MedTech Products, which continues
to use the trade name NIX for this nonprescription product. The
approval of NDA 019918 resulted in what is commonly referred to as a
``full Rx to OTC switch'' for NIX (permethrin) 1% topical creme rinse.
In a letter dated April 12, 2002, and an amendment to that letter dated
July 31, 2020, GlaxoSmithKline requested withdrawal of approval of NDA
019435 for prescription NIX (permethrin) 1% topical creme rinse. In the
Federal Register of December 23, 2020 (85 FR 83973), FDA announced that
it was withdrawing approval of NDA 019435, effective January 22, 2021.
Lachman Consultants submitted a citizen petition dated July 2, 2019
(Docket No. FDA-2019-P-3232), under 21 CFR 10.30, requesting that the
Agency determine whether prescription NIX (permethrin) 1% topical creme
rinse (NDA 019435) was withdrawn from sale for reasons of safety or
effectiveness.
II. FDA Has Determined That Prescription NIX Was Not 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 prescription NIX (permethrin) 1% topical creme
rinse (NDA 019435) was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that prescription NIX (permethrin) 1% topical
creme rinse (NDA 019435) was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of prescription NIX (permethrin) 1% topical
creme rinse (NDA 019435) 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 prescription NIX
(permethrin) 1% topical creme rinse (NDA 019435) 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.
III. Under Section 503 of the FD&C Act, NIX and Any Generic Product
Referencing Prescription NIX Would Be Misbranded if Marketed as
Prescription Drugs
According to section 503(b)(4)(B) of the FD&C Act, a drug not
required to be dispensed with a prescription under section 503(b)(1) of
the FD&C Act shall be deemed to be misbranded if at any time prior to
dispensing the label of the drug bears the ``Rx only'' symbol.
Likewise, per section 503(b)(4)(A) of the
[[Page 57908]]
FD&C Act, drugs that must be dispensed with a prescription under
section 503(b)(1) of the FD&C Act must bear the ``Rx only'' symbol; if
not, they become misbranded. FDA has long interpreted these provisions
to mean that section 503(b) of the FD&C Act does not permit the same
active ingredient to be simultaneously marketed in both a prescription
drug product and a nonprescription drug product unless a meaningful
difference exists between the two that makes the prescription product
safe only under the supervision of a licensed practitioner.
In this instance, based on studies submitted by the sponsor, FDA
determined that the original prescription NIX product no longer met the
criteria in section 503(b)(1) of the FD&C Act for prescription use (see
21 CFR 310.200(b)). Therefore, FDA changed NIX's status from
prescription to nonprescription. This is commonly referred to as a
``full Rx to OTC switch.'' The permethrin 1% topical creme rinse
product (NDA 019918) continued to use the trade name NIX when it
switched from prescription to nonprescription. Because FDA concluded
that there is no meaningful difference between the currently marketed
nonprescription NIX product and its previous prescription version, NIX
would be misbranded under section 503(b)(4)(B) of the FD&C Act if it
were to bear the symbol ``Rx only.'' Similarly, any generic product
referencing prescription NIX (NDA 019435) would also be misbranded
under section 503(b)(4)(B) of the FD&C Act, because it would
necessarily bear the same labeling as that approved under NDA 019435,
including the ``Rx only'' symbol. Moreover, FDA will not approve an
ANDA referencing prescription NIX (NDA 019435).
Dated: September 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20520 Filed 9-21-22; 8:45 am]
BILLING CODE 4164-01-P
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