[Federal Register Volume 88, Number 110 (Thursday, June 8, 2023)]
[Notices]
[Page 37548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Withdrawn From Sale for Reasons of Safety or Effectiveness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(mg), 7.5 mg, 10 mg, and 15 mg, were not withdrawn from sale for 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, [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.
    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