Gemini Laboratories, LLC, et al.; Withdrawal of Approval of One New Drug Application for OXANDRIN (Oxandrolone) Tablets and Four Abbreviated New Drug Applications for Oxandrolone Tablets, 41970-41971 [2023-13733]
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Federal Register / Vol. 88, No. 123 / Wednesday, June 28, 2023 / Notices
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and Drug Administration, 10001 New
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0002. Send one self-addressed adhesive
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your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Dominic Markwordt, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5104,
Silver Spring, MD 20993, 301–796–
3100, Dominic.Markwordt@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
ddrumheller on DSK120RN23PROD with NOTICES1
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Prohibition on Wholesaling Under
Section 503B of the Federal Food, Drug,
and Cosmetic Act.’’ This draft guidance
describes FDA’s interpretation of, and
policies concerning, the prohibition on
wholesaling in section 503B of the
FD&C Act (21 U.S.C. 353b). This draft
guidance also describes examples of
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how FDA intends to apply section 503B
of the FD&C Act’s wholesaling
provision.
Section 503B of the FD&C Act
describes the conditions that must be
satisfied for human drugs compounded
by an outsourcing facility to be exempt
from the following three sections of the
FD&C Act: section 505 (21 U.S.C. 355)
(concerning the approval of drugs under
new drug applications or abbreviated
new drug applications); section 502(f)(1)
(21 U.S.C. 352(f)(1)) (concerning the
labeling of drugs with adequate
directions for use); and section 582 (21
U.S.C. 360eee-1) (concerning drug
supply chain security requirements).
Pursuant to section 503B(a)(8) of the
FD&C Act, one of the conditions that
must be met for a drug compounded by
an outsourcing facility to qualify for the
exemptions in section 503B of the FD&C
Act is that the drug will not be sold or
transferred by an entity other than the
outsourcing facility that compounded
the drug. However, the wholesaling
provision does not prohibit
administration of a drug in a health care
setting or dispensing a drug pursuant to
a prescription executed in accordance
with section 503(b)(1) of the FD&C Act.
The statutory prohibition on
wholesaling in section 503B(a)(8) of the
FD&C Act helps to ensure that
compounding is based on individual
patient need, which, in turn, reduces
the overall risk of patient harm and
helps to preserve the integrity of the
U.S. drug approval process. It also helps
to preserve the integrity of the U.S. drug
supply chain. This prohibition, like
other conditions in section 503B of the
FD&C Act, preserves important
distinctions between outsourcing
facilities, which are intended to
compound drugs for patients whose
medical needs cannot be met by
approved drugs, from conventional
manufacturers, which generally engage
in mass manufacturing of FDAapproved drug 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 the ‘‘Prohibition on Wholesaling
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.’’ It does
not establish any rights for any person
and is not binding on FDA or the public.
An alternative approach than what is
described in the guidance can be used
if it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this draft guidance contains no
collection of information, it does refer to
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previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 207
pertaining to registration of producers of
drugs and listing of drugs in commercial
distribution have been approved under
OMB control number 0910–0045. The
collections of information in 21 CFR
parts 210 and 211 pertaining to current
good manufacturing practice have been
approved under OMB control number
0910–0139. The collections of
information pertaining to postmarketing
adverse drug experience reporting have
been approved under OMB control
number 0910–0230. The collections of
information for adverse event reporting
and human drug compounding under
section 503B of the FD&C Act have been
approved under OMB control number
0910–0800.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents,
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs or https://
www.regulations.gov.
Dated: June 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–13767 Filed 6–27–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2226]
Gemini Laboratories, LLC, et al.;
Withdrawal of Approval of One New
Drug Application for OXANDRIN
(Oxandrolone) Tablets and Four
Abbreviated New Drug Applications for
Oxandrolone Tablets
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of the new drug
application (NDA) for OXANDRIN
(oxandrolone) tablets, 2.5 milligrams
(mg) and 10 mg, held by Gemini
Laboratories, LLC (Gemini). Gemini
SUMMARY:
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Federal Register / Vol. 88, No. 123 / Wednesday, June 28, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
voluntarily requested withdrawal of this
application and waived its opportunity
for a hearing. In addition, FDA is
withdrawing approval of four
abbreviated new drug applications
(ANDAs) for oxandrolone tablets from
multiple ANDA holders. Upsher-Smith
Laboratories, LLC (Upsher-Smith), Par
Pharmaceutical, Inc. (Par), and Sandoz
Inc. (Sandoz) voluntarily requested
withdrawal of their respective
applications and waived their
opportunity for a hearing.
DATES: Approval is withdrawn as of
June 28, 2023.
FOR FURTHER INFORMATION CONTACT:
Alexandria Fujisaki, Center for Drug
Evaluation and Research, Food and
41971
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6222,
Silver Spring, MD 20993–0002, 301–
796–3600, Alexandria.Fujisaki@
fda.hhs.gov.
The
applicants and their respective drugs
and applications are included in the
following table.
SUPPLEMENTARY INFORMATION:
Application No.
Drug
Applicant
NDA 013718 ..........
Oxandrin (oxandrolone) Tablets, 2.5 mg and 10 mg .............
ANDA 076761 ........
Oxandrolone Tablets, 2.5 mg .................................................
ANDA 076897 ........
ANDA 077827 ........
Oxandrolone Tablets, 2.5 mg and 10 mg ..............................
Oxandrolone Tablets, 2.5 mg and 10 mg ..............................
ANDA 078033 ........
Oxandrolone Tablets, 10 mg ..................................................
Gemini, 400 Crossing Blvd., 5th Floor, Bridgewater, NJ
08807.
Upsher-Smith Laboratories, LLC, 6701 Evenstad Dr., Maple
Grove, MN 55369.
Sandoz Inc., 100 College Rd. West, Princeton, NJ 08540.
Par Pharmaceutical, Inc., c/o Endo, 1400 Atwater Dr., Malvern, PA 19355.
Upsher-Smith Laboratories, LLC, 6701 Evenstad Dr., Maple
Grove, MN 55369.
In a letter dated March 26, 2019,
Gemini requested that FDA withdraw
approval of NDA 013718 for
OXANDRIN (oxandrolone) tablets, 2.5
mg and 10 mg, under § 314.150(c) (21
CFR 314.150(c)), stating that the product
was no longer being marketed.
Subsequently, on December 16, 2022,
FDA notified Gemini and other holders
of approved applications that the
Agency believes a potential problem
associated with oxandrolone tablets is
sufficiently serious that the drug
products should be removed from the
market, and to enable withdrawal of
approval of their applications under
§ 314.150(d).
The anabolic steroid OXANDRIN
(oxandrolone) tablets, 2.5 mg and 10 mg,
under NDA 013718, is indicated as
follows: ‘‘as adjunctive therapy to
promote weight gain after weight loss
following extensive surgery, chronic
infections, or severe trauma, and in
some patients who without definite
pathophysiologic reasons fail to gain or
to maintain normal weight, to offset the
protein catabolism associated with
prolonged administration of
corticosteroids, and for the relief of the
bone pain frequently accompanying
osteoporosis.’’ 1 FDA initially approved
NDA 013718 in 1964.
In January 1984, FDA’s
Endocrinologic and Metabolic Drugs
Advisory Committee met and discussed
anabolic steroids. The advisory
committee unanimously concluded that
there was no evidence of efficacy for
oxandrolone.2
As communicated in the product
labeling, multiple safety warnings and
precautions are associated with the use
of oxandrolone tablets including
peliosis hepatis, sometimes associated
with liver failure and intra-abdominal
hemorrhage; liver cell tumors,
sometimes fatal; and blood lipid
changes that are known to be associated
with increased risk of atherosclerosis.3
Per the labeling, additional warnings
with using this product include the
risks associated with cholestatic
hepatitis, hypercalcemia in patients
with breast cancer, and increased risk
for the development of prostatic
hypertrophy and prostatic carcinoma in
geriatric patients.4
Based on FDA’s review of currently
available data and information regarding
the safety and effectiveness of
oxandrolone tablets, the Agency
believes that the potential problems
associated with oxandrolone tablets are
sufficiently serious that the drug should
be removed from the market.
After FDA notified Gemini that it
believes the potential problems
associated with the drug are sufficiently
serious that the drug should be removed
from the market pursuant to
§ 314.150(d), Gemini requested in a
letter dated December 19, 2022 that FDA
withdraw approval of NDA 013718
under § 314.150(d). Gemini waived its
opportunity for a hearing. In a letter
dated December 23, 2022, Sandoz
requested that FDA withdraw approval
of ANDA 076897 under § 314.150(d).
Sandoz waived its opportunity for a
hearing. In a letter dated January 5,
2023, Par requested that FDA withdraw
approval of ANDA 077827 under
§ 314.150(d). Par waived its opportunity
for a hearing. In separate letters dated
January 6, 2023, Upsher-Smith
requested that FDA withdraw approval
of ANDAs 078033 and 076761 under
§ 314.150(d). Upsher-Smith waived its
opportunity for a hearing.
Therefore, for the reasons discussed
above, which the applicants do not
dispute in their letters requesting
withdrawal of approval under
§ 314.150(d), FDA’s approval of NDA
013718 and ANDAs 076897, 077827,
078033, and 076761, and all
amendments and supplements thereto,
are withdrawn (see DATES).
Distribution of Gemini’s OXANDRIN
(oxandrolone) tablets, 2.5 mg and 10 mg;
Sandoz’s oxandrolone tablets 2.5 mg
and 10 mg; Par’s oxandrolone tablets,
2.5 mg and 10 mg; or Upsher-Smith’s
oxandrolone tablets, 2.5 mg and 10 mg,
into interstate commerce without an
approved application is illegal and
subject to regulatory action (see sections
505(a) and 301(d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
355(a) and 331(d)).
Dated: June 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–13733 Filed 6–27–23; 8:45 am]
BILLING CODE 4164–01–P
2 See
1 See OXANDRIN (oxandrolone) tablets, NDA
013718, product labeling, (rev. June 2005), available
at https://www.accessdata.fda.gov/drugsatfda_
docs/label/2005/013718s023lbl.pdf.
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18:48 Jun 27, 2023
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minutes from the January 24 to 25, 1984,
advisory committee meeting discussing anabolic
steroids, at pg. 7.
3 See OXANDRIN (oxandrolone) tablets, NDA
013718, product labeling, (rev. June 2005).
4 Id.
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]]>Agencies
[Federal Register Volume 88, Number 123 (Wednesday, June 28, 2023)]
[Notices]
[Pages 41970-41971]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13733]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2226]
Gemini Laboratories, LLC, et al.; Withdrawal of Approval of One
New Drug Application for OXANDRIN (Oxandrolone) Tablets and Four
Abbreviated New Drug Applications for Oxandrolone Tablets
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of the new drug application (NDA) for OXANDRIN
(oxandrolone) tablets, 2.5 milligrams (mg) and 10 mg, held by Gemini
Laboratories, LLC (Gemini). Gemini
[[Page 41971]]
voluntarily requested withdrawal of this application and waived its
opportunity for a hearing. In addition, FDA is withdrawing approval of
four abbreviated new drug applications (ANDAs) for oxandrolone tablets
from multiple ANDA holders. Upsher-Smith Laboratories, LLC (Upsher-
Smith), Par Pharmaceutical, Inc. (Par), and Sandoz Inc. (Sandoz)
voluntarily requested withdrawal of their respective applications and
waived their opportunity for a hearing.
DATES: Approval is withdrawn as of June 28, 2023.
FOR FURTHER INFORMATION CONTACT: Alexandria Fujisaki, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6222, Silver Spring, MD 20993-0002, 301-
796-3600, [email protected].
SUPPLEMENTARY INFORMATION: The applicants and their respective drugs
and applications are included in the following table.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 013718............... Oxandrin (oxandrolone) Gemini, 400 Crossing
Tablets, 2.5 mg and Blvd., 5th Floor,
10 mg. Bridgewater, NJ
08807.
ANDA 076761.............. Oxandrolone Tablets, Upsher-Smith
2.5 mg. Laboratories, LLC,
6701 Evenstad Dr.,
Maple Grove, MN
55369.
ANDA 076897.............. Oxandrolone Tablets, Sandoz Inc., 100
2.5 mg and 10 mg. College Rd. West,
Princeton, NJ 08540.
ANDA 077827.............. Oxandrolone Tablets, Par Pharmaceutical,
2.5 mg and 10 mg. Inc., c/o Endo, 1400
Atwater Dr.,
Malvern, PA 19355.
ANDA 078033.............. Oxandrolone Tablets, Upsher-Smith
10 mg. Laboratories, LLC,
6701 Evenstad Dr.,
Maple Grove, MN
55369.
------------------------------------------------------------------------
In a letter dated March 26, 2019, Gemini requested that FDA
withdraw approval of NDA 013718 for OXANDRIN (oxandrolone) tablets, 2.5
mg and 10 mg, under Sec. 314.150(c) (21 CFR 314.150(c)), stating that
the product was no longer being marketed. Subsequently, on December 16,
2022, FDA notified Gemini and other holders of approved applications
that the Agency believes a potential problem associated with
oxandrolone tablets is sufficiently serious that the drug products
should be removed from the market, and to enable withdrawal of approval
of their applications under Sec. 314.150(d).
The anabolic steroid OXANDRIN (oxandrolone) tablets, 2.5 mg and 10
mg, under NDA 013718, is indicated as follows: ``as adjunctive therapy
to promote weight gain after weight loss following extensive surgery,
chronic infections, or severe trauma, and in some patients who without
definite pathophysiologic reasons fail to gain or to maintain normal
weight, to offset the protein catabolism associated with prolonged
administration of corticosteroids, and for the relief of the bone pain
frequently accompanying osteoporosis.'' \1\ FDA initially approved NDA
013718 in 1964.
---------------------------------------------------------------------------
\1\ See OXANDRIN (oxandrolone) tablets, NDA 013718, product
labeling, (rev. June 2005), available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013718s023lbl.pdf.
---------------------------------------------------------------------------
In January 1984, FDA's Endocrinologic and Metabolic Drugs Advisory
Committee met and discussed anabolic steroids. The advisory committee
unanimously concluded that there was no evidence of efficacy for
oxandrolone.\2\
---------------------------------------------------------------------------
\2\ See minutes from the January 24 to 25, 1984, advisory
committee meeting discussing anabolic steroids, at pg. 7.
---------------------------------------------------------------------------
As communicated in the product labeling, multiple safety warnings
and precautions are associated with the use of oxandrolone tablets
including peliosis hepatis, sometimes associated with liver failure and
intra-abdominal hemorrhage; liver cell tumors, sometimes fatal; and
blood lipid changes that are known to be associated with increased risk
of atherosclerosis.\3\ Per the labeling, additional warnings with using
this product include the risks associated with cholestatic hepatitis,
hypercalcemia in patients with breast cancer, and increased risk for
the development of prostatic hypertrophy and prostatic carcinoma in
geriatric patients.\4\
---------------------------------------------------------------------------
\3\ See OXANDRIN (oxandrolone) tablets, NDA 013718, product
labeling, (rev. June 2005).
\4\ Id.
---------------------------------------------------------------------------
Based on FDA's review of currently available data and information
regarding the safety and effectiveness of oxandrolone tablets, the
Agency believes that the potential problems associated with oxandrolone
tablets are sufficiently serious that the drug should be removed from
the market.
After FDA notified Gemini that it believes the potential problems
associated with the drug are sufficiently serious that the drug should
be removed from the market pursuant to Sec. 314.150(d), Gemini
requested in a letter dated December 19, 2022 that FDA withdraw
approval of NDA 013718 under Sec. 314.150(d). Gemini waived its
opportunity for a hearing. In a letter dated December 23, 2022, Sandoz
requested that FDA withdraw approval of ANDA 076897 under Sec.
314.150(d). Sandoz waived its opportunity for a hearing. In a letter
dated January 5, 2023, Par requested that FDA withdraw approval of ANDA
077827 under Sec. 314.150(d). Par waived its opportunity for a
hearing. In separate letters dated January 6, 2023, Upsher-Smith
requested that FDA withdraw approval of ANDAs 078033 and 076761 under
Sec. 314.150(d). Upsher-Smith waived its opportunity for a hearing.
Therefore, for the reasons discussed above, which the applicants do
not dispute in their letters requesting withdrawal of approval under
Sec. 314.150(d), FDA's approval of NDA 013718 and ANDAs 076897,
077827, 078033, and 076761, and all amendments and supplements thereto,
are withdrawn (see DATES). Distribution of Gemini's OXANDRIN
(oxandrolone) tablets, 2.5 mg and 10 mg; Sandoz's oxandrolone tablets
2.5 mg and 10 mg; Par's oxandrolone tablets, 2.5 mg and 10 mg; or
Upsher-Smith's oxandrolone tablets, 2.5 mg and 10 mg, into interstate
commerce without an approved application is illegal and subject to
regulatory action (see sections 505(a) and 301(d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)).
Dated: June 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13733 Filed 6-27-23; 8:45 am]
BILLING CODE 4164-01-P
