[Federal Register Volume 89, Number 71 (Thursday, April 11, 2024)]
[Notices]
[Pages 25631-25632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07707]


-----------------------------------------------------------------------

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Suspension, 25 Milligrams/5 Milliliters, Was Not Withdrawn From Sale 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.

-----------------------------------------------------------------------

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milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for 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, [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.
    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