Notice2023-12247
Determination That BUSPAR (Buspirone Hydrochloride) Capsules, 5 Milligrams, 7.5 Milligrams, 10 Milligrams, and 15 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
June 8, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) has determined that BUSPAR (buspirone hydrochloride) capsules, 5 milligrams (mg), 7.5 mg, 10 mg, and 15 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDA) for buspirone hydrochloride capsules, 5 mg, 7.5 mg, 10 mg, and 15 mg, if all other legal and regulatory requirements are met.
Full Text
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<title>Federal Register, Volume 88 Issue 110 (Thursday, June 8, 2023)</title>
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[Federal Register Volume 88, Number 110 (Thursday, June 8, 2023)]
[Notices]
[Page 37548]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-12247]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-P-0120]
Determination That BUSPAR (Buspirone Hydrochloride) Capsules, 5
Milligrams, 7.5 Milligrams, 10 Milligrams, and 15 Milligrams, Were 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Withdrawn From Sale for Reasons of Safety or Effectiveness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 BUSPAR (buspirone hydrochloride) capsules, 5 milligrams
(mg), 7.5 mg, 10 mg, and 15 mg, were not withdrawn from sale for
reasons of safety or effectiveness. This determination will allow FDA
to approve abbreviated new drug applications (ANDA) for buspirone
hydrochloride capsules, 5 mg, 7.5 mg, 10 mg, and 15 mg, if all other
legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Caitlin Callahan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 240-
402-4318, <a href="/cdn-cgi/l/email-protection#86c5e7eff2eaefe8a8c5e7eaeae7eee7e8c6e0e2e7a8eeeef5a8e1e9f0"><span class="__cf_email__" data-cfemail="c784a6aeb3abaea9e984a6ababa6afa6a987a1a3a6e9afafb4e9a0a8b1">[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.
BUSPAR (buspirone hydrochloride) capsules, 5 mg, 7.5 mg, 10 mg, and
15 mg, are the subject of NDA 021190, held by Bristol Myers Squibb Co.,
and initially approved on December 20, 2000. BUSPAR is indicated for
the management of anxiety disorders or the short-term relief of the
symptoms of anxiety.
In correspondence dated December 28, 2012, Bristol Myers Squibb Co.
requested withdrawal of NDA 021190 for BUSPAR (buspirone
hydrochloride). In the Federal Register of December 5, 2014 (79 FR
72186), FDA announced that it was withdrawing approval of NDA 021190,
effective January 5, 2015.
Epic Pharma, LLC submitted a citizen petition dated January 10,
2023 (Docket No. FDA-2023-P-0120), under 21 CFR 10.30, requesting that
the Agency determine whether BUSPAR (buspirone hydrochloride) capsules,
5 mg, 7.5 mg, 10 mg, and 15 mg, were 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 BUSPAR (buspirone hydrochloride) capsules, 5
mg, 7.5 mg, 10 mg, and 15 mg, were not withdrawn for reasons of safety
or effectiveness. The petitioner has identified no data or other
information suggesting that BUSPAR (buspirone hydrochloride) capsules,
5 mg, 7.5 mg, 10 mg, and 15 mg, were withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of BUSPAR (buspirone hydrochloride) capsules,
5 mg, 7.5 mg, 10 mg, and 15 mg, 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.\1\
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\1\ FDA previously determined that BUSPAR (buspirone
hydrochloride) tablets, 5 mg, 10 mg, 15 mg, and 30 mg, approved
under NDA 018731 and held by Bristol Myers Squibb Co. Pharmaceutical
Research Institute, were not withdrawn from sale for reasons of
safety or effectiveness. See 75 FR 64310 (October 19, 2010), 81 FR
61220 (September 6, 2016).
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Accordingly, the Agency will continue to list BUSPAR (buspirone
hydrochloride) capsules, 5 mg, 7.5 mg, 10 mg, and 15 mg, 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 BUSPAR (buspirone
hydrochloride) capsules, 5 mg, 7.5 mg, 10 mg, and 15 mg, 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: June 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-12247 Filed 6-7-23; 8:45 am]
BILLING CODE 4164-01-P
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