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[Federal Register Volume 89, Number 219 (Wednesday, November 13, 2024)]
[Notices]
[Pages 89647-89648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-26318]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-P-2514]

Determination That NUPLAZID (Pimavanserin Tartrate) Tablet, 
Equivalent 17 Milligram Base, Was Not Withdrawn From Sale for Reasons 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 or Agency) has 
determined that NUPLAZID (pimavanserin tartrate) tablet, equivalent 
(EQ) 17 milligram (mg) base, was not withdrawn from sale for reasons of 
safety or effectiveness. This determination will allow FDA to approve 
abbreviated new drug applications (ANDAs) for NUPLAZID (pimavanserin 
tartrate) tablet, EQ 17 mg base, if all other legal and regulatory 
requirements are met.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363, 
[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

[[Page 89648]]

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.
    NUPLAZID (pimavanserin tartrate) tablet, EQ 17 mg base, is the 
subject of NDA 207318, held by Acadia Pharmaceuticals, Inc., and 
initially approved on April 29, 2016. NUPLAZID is an atypical 
antipsychotic indicated for the treatment of hallucinations and 
delusions associated with Parkinson's disease psychosis.
    In a letter dated January 8, 2019, Acadia Pharmaceuticals, Inc., 
notified FDA that NUPLAZID (pimavanserin tartrate) tablet, EQ 17 mg 
base, was being discontinued, and FDA moved the drug product to the 
``Discontinued Drug Product List'' section of the Orange Book.
    Zydus Pharmaceuticals (USA), Inc., submitted a citizen petition 
dated May 22, 2024 (Docket No. FDA-2024-P-2514), under 21 CFR 10.30, 
requesting that the Agency determine whether NUPLAZID (pimavanserin 
tartrate) tablet, EQ 17 mg base, 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 NUPLAZID (pimavanserin tartrate) tablet, EQ 17 
mg base, was not withdrawn for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
NUPLAZID (pimavanserin tartrate) tablet, EQ 17 mg base, was withdrawn 
for reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of NUPLAZID (pimavanserin 
tartrate) tablet, EQ 17 mg base, 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 NUPLAZID 
(pimavanserin tartrate) tablet, EQ 17 mg base, 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 NUPLAZID (pimavanserin tartrate) 
oral tablet, EQ 17 mg base, 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: November 6, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-26318 Filed 11-12-24; 8:45 am]
BILLING CODE 4164-01-P
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