[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Equivalent 17 Milligram Base, Was Not Withdrawn From Sale for Reasons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(EQ) 17 milligram (mg) base, was not withdrawn from sale for reasons of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FDA determines that the listed drug was withdrawn from sale for reasons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