Determination That HYDROCORTONE (Hydrocortisone Sodium Phosphate) Injection, Equivalent to 50 Milligrams Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 91405-91406 [2024-26916]
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Federal Register / Vol. 89, No. 223 / Tuesday, November 19, 2024 / Notices
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
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You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the Office
of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The draft guidance may also be
obtained by mail by calling CBER at 1–
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the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Myrna Hanna, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
ddrumheller on DSK120RN23PROD with NOTICES1
I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Frequently
asked Questions—Developing Potential
Cellular and Gene Therapy Products.’’
The draft guidance document provides
industry with answers to FAQs and
commonly faced issues that arise during
the development of CGT products. The
FAQs represent common questions
directed to the Agency and span
multiple disciplines, including
regulatory review; CMC; pharmacology/
toxicology; clinical; and clinical
pharmacology.
The guidance was created as part of
FDA’s response to the PDUFA VII
commitment to increase efficiency and
to support development of CGT
products by providing a repository of
common questions posed to the Office
of Therapeutic Products by sponsors
and other key stakeholders. The Agency
compiled FAQs received from a variety
of sources, including FDA interactions
with sponsors in development
programs.
The guidance covers relevant, current,
and timely topics related to the
VerDate Sep<11>2014
17:42 Nov 18, 2024
Jkt 265001
development of CGT products, which
may be updated to include additional
FAQs as appropriate. Sponsors are
encouraged to visit the Cellular and
Gene Therapy Guidances web page on
the FDA website for a full list of
finalized as well as draft guidances
relevant to the development of CGT
products.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Frequently asked Questions—
Developing Potential Cellular and Gene
Therapy Products.’’ It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Action of 1995 (44 U.S.C.
3501–3521). The collections of
information in 21 CFR part 312
pertaining to investigational new drug
applications, clinical trials and clinical
trial design, meetings with FDA, and
Form FDA 1571, have been approved
under OMB control number 0910–0014.
The collections of information in
section 402(j)(5)(B) of the Public Health
Service Act (42 U.S.C. 282(j)(5)(B)),
which requires certification that all
applicable requirements of section
402(j) have been met on Form FDA
3674, and the collections of information
in 21 CFR part 601 pertaining to the
submission of biologics license
applications and Form FDA 356h have
been approved under OMB control
number 0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: November 7, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–26918 Filed 11–18–24; 8:45 am]
BILLING CODE 4164–01–P
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91405
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–P–1991 and FDA–
2021–P–0940]
Determination That HYDROCORTONE
(Hydrocortisone Sodium Phosphate)
Injection, Equivalent to 50 Milligrams
Base/Milliliter, Was Not Withdrawn
From Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that HYDROCORTONE
(hydrocortisone sodium phosphate)
injection, equivalent to (EQ) 50
milligrams (mg) base/milliliter (mL),
was not withdrawn from sale for reasons
of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for
HYDROCORTONE (hydrocortisone
sodium phosphate) injection, EQ 50 mg
base/mL, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT: Beth
Holck, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6280, Silver Spring,
MD 20993–0002, 240–402–7133,
Beth.Holck@fda.hhs.gov.
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
SUMMARY:
E:\FR\FM\19NON1.SGM
19NON1
ddrumheller on DSK120RN23PROD with NOTICES1
91406
Federal Register / Vol. 89, No. 223 / Tuesday, November 19, 2024 / Notices
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.
HYDROCORTONE (hydrocortisone
sodium phosphate) injection, EQ 50 mg
base/mL, is the subject of NDA 012052,
held by Merck & Co., Inc., and initially
approved on June 8, 1960.
HYDROCORTONE (hydrocortisone
sodium phosphate) injection, EQ 50 mg
base/mL, is synthetic glucocorticoid for
use as an anti-inflammatory or
immunosuppressant agent.
The indications for glucocorticoid
drugs, including HYDROCORTONE
(hydrocortisone sodium phosphate)
injection, EQ 50 mg base/mL (Merck
Sharpe & Dohme (now Merck & Co.,
Inc.); NDA 012052) were reviewed for
efficacy under the Drug Efficacy Study
Implementation program. Under this
program, which was implemented in
response to the 1962 amendments to the
FD&C Act requiring demonstration of
effectiveness (Kefauver-Harris
Amendments of 1962 (Pub. L. 87–781)),
the National Academy of SciencesNational Research Council (NAS–NRC)
studied about 4,000 drug formulations
to assess the efficacy of the drug
products. Upon consideration of the
findings and recommendations of the
NAS–NRC, FDA set forth in the Federal
Register its conclusions and assessment
of whether and under what
circumstances the reviewed drug
products are considered ‘‘effective’’ for
use as required by the FD&C Act. In the
Federal Register of February 19, 1972
(37 FR 3775), FDA announced that
preparations containing hydrocortisone
sodium phosphate are effective or
probably effective for parenteral use by
the appropriate route of administration.
FDA published a subsequent notice in
the Federal Register of March 1, 1977
(42 FR 11893), in which the Agency set
forth the indications that it found to be
effective for certain drug products,
including for HYDROCORTONE
(hydrocortisone sodium phosphate)
injection, EQ 50 mg base/mL (NDA
012052). The March 1, 1977, notice
announced FDA was prepared to
VerDate Sep<11>2014
17:42 Nov 18, 2024
Jkt 265001
approve NDAs and supplements to
previously approved NDAs under the
conditions described in the notice,
including the condition that the revised
labeling include only the indications for
which the drug was classified as
effective set forth in that notice (42 FR
11893 at 11894–5).
HYDROCORTONE (hydrocortisone
sodium phosphate) injection, EQ 50 mg
base/mL, is currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. In a letter
dated April 4, 2003, Merck & Co., Inc.,
notified FDA that HYDROCORTONE
(hydrocortisone sodium phosphate)
injection, EQ 50 mg base/mL, was
discontinued effective September 20,
2002. In the same letter, Merck & Co.,
Inc., also requested withdrawal of NDA
012052 for HYDROCORTONE
(hydrocortisone sodium phosphate), and
FDA moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book. In the
Federal Register of May 5, 2004 (69 FR
25124), FDA announced that it was
withdrawing approval of NDA 012052,
effective June 4, 2004.
Hyman, Phelps & McNamara, P.C.,
submitted an initial citizen petition
dated September 21, 2020 (Docket No.
FDA–2020–P–1991) as well as a second
citizen petition dated August 25, 2021
(Docket No. FDA–2021–P–0940), under
21 CFR 10.30, requesting that the
Agency determine whether
HYDROCORTONE (hydrocortisone
sodium phosphate) injection, EQ 50 mg
base/mL, was withdrawn from sale for
reasons of safety or effectiveness.
After considering the citizen petitions
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that HYDROCORTONE
(hydrocortisone sodium phosphate)
injection, EQ 50 mg base/mL, was not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that HYDROCORTONE
(hydrocortisone sodium phosphate)
injection, EQ 50 mg base/mL, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
HYDROCORTONE (hydrocortisone
sodium phosphate) injection, EQ 50 mg
base/mL, 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.
PO 00000
Frm 00094
Fmt 4703
Sfmt 4703
Accordingly, the Agency will
continue to list HYDROCORTONE
(hydrocortisone sodium phosphate)
injection, EQ 50 mg base/mL, 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 HYDROCORTONE (hydrocortisone
sodium phosphate) injection, EQ 50 mg
base/mL, may be approved by the
Agency if 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 7, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–26916 Filed 11–18–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–3111]
Ivette Maria Portela Martinez: Final
Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) permanently
debarring Ivette Maria Portela Martinez
from providing services in any capacity
to a person that has an approved or
pending drug product application. FDA
bases this order on a finding that Ms.
Portela Martinez was convicted of two
felonies under Federal law for conduct
relating to the development or approval,
including the process for development
or approval, of any drug product. Ms.
Portela Martinez was given notice of the
proposed debarment and an opportunity
to request a hearing within the
timeframe prescribed by regulation. As
of September 14, 2024 (30 days after
receipt of the notice), Ms. Portela
Martinez has not responded. Ms. Portela
Martinez’s failure to respond and
request a hearing constitutes a waiver of
Ms. Portela Martinez’s right to a hearing
concerning this matter.
SUMMARY:
E:\FR\FM\19NON1.SGM
19NON1
]]>Agencies
[Federal Register Volume 89, Number 223 (Tuesday, November 19, 2024)]
[Notices]
[Pages 91405-91406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-26916]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2020-P-1991 and FDA-2021-P-0940]
Determination That HYDROCORTONE (Hydrocortisone Sodium Phosphate)
Injection, Equivalent to 50 Milligrams Base/Milliliter, Was 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 or Agency) has
determined that HYDROCORTONE (hydrocortisone sodium phosphate)
injection, equivalent to (EQ) 50 milligrams (mg) base/milliliter (mL),
was not withdrawn from sale for reasons of safety or effectiveness.
This determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for HYDROCORTONE (hydrocortisone sodium phosphate)
injection, EQ 50 mg base/mL, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT: Beth Holck, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 240-402-7133,
[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
[[Page 91406]]
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.
HYDROCORTONE (hydrocortisone sodium phosphate) injection, EQ 50 mg
base/mL, is the subject of NDA 012052, held by Merck & Co., Inc., and
initially approved on June 8, 1960. HYDROCORTONE (hydrocortisone sodium
phosphate) injection, EQ 50 mg base/mL, is synthetic glucocorticoid for
use as an anti-inflammatory or immunosuppressant agent.
The indications for glucocorticoid drugs, including HYDROCORTONE
(hydrocortisone sodium phosphate) injection, EQ 50 mg base/mL (Merck
Sharpe & Dohme (now Merck & Co., Inc.); NDA 012052) were reviewed for
efficacy under the Drug Efficacy Study Implementation program. Under
this program, which was implemented in response to the 1962 amendments
to the FD&C Act requiring demonstration of effectiveness (Kefauver-
Harris Amendments of 1962 (Pub. L. 87-781)), the National Academy of
Sciences-National Research Council (NAS-NRC) studied about 4,000 drug
formulations to assess the efficacy of the drug products. Upon
consideration of the findings and recommendations of the NAS-NRC, FDA
set forth in the Federal Register its conclusions and assessment of
whether and under what circumstances the reviewed drug products are
considered ``effective'' for use as required by the FD&C Act. In the
Federal Register of February 19, 1972 (37 FR 3775), FDA announced that
preparations containing hydrocortisone sodium phosphate are effective
or probably effective for parenteral use by the appropriate route of
administration.
FDA published a subsequent notice in the Federal Register of March
1, 1977 (42 FR 11893), in which the Agency set forth the indications
that it found to be effective for certain drug products, including for
HYDROCORTONE (hydrocortisone sodium phosphate) injection, EQ 50 mg
base/mL (NDA 012052). The March 1, 1977, notice announced FDA was
prepared to approve NDAs and supplements to previously approved NDAs
under the conditions described in the notice, including the condition
that the revised labeling include only the indications for which the
drug was classified as effective set forth in that notice (42 FR 11893
at 11894-5).
HYDROCORTONE (hydrocortisone sodium phosphate) injection, EQ 50 mg
base/mL, is currently listed in the ``Discontinued Drug Product List''
section of the Orange Book. In a letter dated April 4, 2003, Merck &
Co., Inc., notified FDA that HYDROCORTONE (hydrocortisone sodium
phosphate) injection, EQ 50 mg base/mL, was discontinued effective
September 20, 2002. In the same letter, Merck & Co., Inc., also
requested withdrawal of NDA 012052 for HYDROCORTONE (hydrocortisone
sodium phosphate), and FDA moved the drug product to the ``Discontinued
Drug Product List'' section of the Orange Book. In the Federal Register
of May 5, 2004 (69 FR 25124), FDA announced that it was withdrawing
approval of NDA 012052, effective June 4, 2004.
Hyman, Phelps & McNamara, P.C., submitted an initial citizen
petition dated September 21, 2020 (Docket No. FDA-2020-P-1991) as well
as a second citizen petition dated August 25, 2021 (Docket No. FDA-
2021-P-0940), under 21 CFR 10.30, requesting that the Agency determine
whether HYDROCORTONE (hydrocortisone sodium phosphate) injection, EQ 50
mg base/mL, was withdrawn from sale for reasons of safety or
effectiveness.
After considering the citizen petitions and reviewing Agency
records and based on the information we have at this time, FDA has
determined under Sec. 314.161 that HYDROCORTONE (hydrocortisone sodium
phosphate) injection, EQ 50 mg base/mL, was not withdrawn for reasons
of safety or effectiveness. The petitioner has identified no data or
other information suggesting that HYDROCORTONE (hydrocortisone sodium
phosphate) injection, EQ 50 mg base/mL, was withdrawn for reasons of
safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of HYDROCORTONE (hydrocortisone
sodium phosphate) injection, EQ 50 mg base/mL, 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 HYDROCORTONE
(hydrocortisone sodium phosphate) injection, EQ 50 mg base/mL, 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 HYDROCORTONE
(hydrocortisone sodium phosphate) injection, EQ 50 mg base/mL, may be
approved by the Agency if 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 7, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-26916 Filed 11-18-24; 8:45 am]
BILLING CODE 4164-01-P
