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BUSPAR (Buspirone Hydrochloride) Capsules, 5 Milligrams, 7.5 Milligrams, 10 Milligrams, and 15 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 37548 [2023-12247]
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37548
Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Notices
Dated: June 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–12249 Filed 6–7–23; 8:45 am]
BILLING CODE 4164–01–P
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Not Withdrawn From Sale for Reasons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.
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mg, were not withdrawn from sale for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, Caitlin.Callahan@
fda.hhs.gov.
SUMMARY:
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
ddrumheller on DSK120RN23PROD with NOTICES1
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
16:15 Jun 07, 2023
Jkt 259001
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 (§ 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
§ 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
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
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
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2136]
Advisory Committee; Antimicrobial
Drugs Advisory Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of Federal
advisory committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Antimicrobial Drugs
Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Antimicrobial
Drugs Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until the October 7, 2024,
expiration date.
SUMMARY:
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).
E:\FR\FM\08JNN1.SGM
08JNN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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
