Notice2024-07707
Determination That VISTARIL (Hydroxyzine Pamoate) Oral Suspension, 25 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
April 11, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) has determined that VISTARIL (hydroxyzine pamoate) Oral Suspension, 25 milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness.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 VISTARIL (hydroxyzine pamoate) Oral Suspension, 25 mg/5 mL, if all other legal and regulatory requirements are met.
Full Text
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<title>Federal Register, Volume 89 Issue 71 (Thursday, April 11, 2024)</title>
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[Federal Register Volume 89, Number 71 (Thursday, April 11, 2024)]
[Notices]
[Pages 25631-25632]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-07707]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-P-5095]
Determination That VISTARIL (Hydroxyzine Pamoate) Oral
Suspension, 25 Milligrams/5 Milliliters, Was Not Withdrawn From Sale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 VISTARIL (hydroxyzine pamoate) Oral Suspension, 25
milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for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 VISTARIL
(hydroxyzine pamoate) Oral Suspension, 25 mg/5 mL, if all other legal
and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Awo Archampong-Gray, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6243, Silver Spring, MD 20993-0002, 301-
796-0110, <a href="/cdn-cgi/l/email-protection#c786b0a8e986b5a4afa6aab7a8a9a0ea80b5a6be87a1a3a6e9afafb4e9a0a8b1"><span class="__cf_email__" data-cfemail="37764058197645545f565a475859501a7045564e77515356195f5f4419505841">[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 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.
VISTARIL (hydroxyzine pamoate) Oral Suspension, 25 mg/5 mL, is the
subject of NDA 011795, held by Pfizer Inc., and initially approved on
June 3, 1959. VISTARIL is indicated for symptomatic relief of anxiety
and tension associated with psychoneurosis and as an adjunct in organic
disease states in which anxiety is manifested. It is also useful in the
management of pruritus due to allergic conditions such as chronic
urticaria and atopic and contact dermatoses, and in histamine-mediated
pruritus. It is also indicated as a sedative when used as premedication
and following general anesthesia. VISTARIL (hydroxyzine pamoate) Oral
Suspension, 25 mg/5 mL, is currently listed in the ``Discontinued Drug
Product List'' section of the Orange Book.
Hyman, Phelps & McNamara, P.C. submitted a citizen petition dated
November 17, 2023 (Docket No. FDA-2023-P-5095), under 21 CFR 10.30,
requesting that the Agency determine whether VISTARIL (hydroxyzine
pamoate) Oral Suspension, 25 mg/5 mL, has been voluntarily withdrawn
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 VISTARIL (hydroxyzine pamoate) Oral
Suspension, 25 mg/5 mL, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that VISTARIL (hydroxyzine pamoate) Oral
Suspension, 25 mg/5 mL, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of VISTARIL (hydroxyzine pamoate) Oral
Suspension, 25 mg/5 mL, 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
[[Page 25632]]
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list VISTARIL (hydroxyzine
pamoate) Oral Suspension, 25 mg/5 mL, 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. ANDAs that refer to VISTARIL (hydroxyzine pamoate) Oral
Suspension, 25 mg/5 mL, may 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: April 8, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-07707 Filed 4-10-24; 8:45 am]
BILLING CODE 4164-01-P
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