Notice2023-19796
Determination That Oxandrin (Oxandrolone) Tablets, 2.5 Milligrams and 10 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 13, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) has determined that Oxandrin (oxandrolone) tablets, 2.5 milligrams (mg) and 10 mg, were withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg.
Full Text
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<title>Federal Register, Volume 88 Issue 176 (Wednesday, September 13, 2023)</title>
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[Federal Register Volume 88, Number 176 (Wednesday, September 13, 2023)]
[Notices]
[Pages 62799-62800]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-19796]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-P-0558]
Determination That Oxandrin (Oxandrolone) Tablets, 2.5 Milligrams
and 10 Milligrams, Were Withdrawn From Sale for Reasons of Safety or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 Oxandrin (oxandrolone) tablets, 2.5 milligrams (mg) and
10 mg, were withdrawn from sale for reasons of safety or effectiveness.
The Agency will not accept or approve abbreviated new drug applications
(ANDAs) for Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg.
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, <a href="/cdn-cgi/l/email-protection#551439302d343b31273c347b13203f3c26343e3c153331347b3d3d267b323a23"><span class="__cf_email__" data-cfemail="0849646d7069666c7a6169264e7d62617b696361486e6c692660607b266f677e">[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 (Sec. 314.162 (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.
The anabolic steroid Oxandrin (oxandrolone) tablets, 2.5 mg and 10
mg, is the subject of NDA 013718, held by Gemini Laboratories LLC
(Gemini), and initially approved on July 21, 1964 (for the 2.5 mg
strength) and November 5, 2001 (for the 10 mg strength). Oxandrin 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\
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\1\ See Oxandrin (oxandrolone) tablets product labeling (NDA
013718, supplement 023), approved on June 20, 2005, available at
<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013718s023lbl.pdf">https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013718s023lbl.pdf</a>.
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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 that the Agency believes a potential problem
associated with oxandrolone tablets is sufficiently serious that the
drug product should be removed from the market, and to enable
withdrawal of approval of its application under Sec. 314.150(d). 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 for Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg under Sec.
314.150(d). In the Federal Register of June 28, 2023 (88 FR 41970), FDA
announced that it was withdrawing approval of NDA 013718, effective
June 28, 2023.
Novitium Pharma LLC submitted a citizen petition dated April 6,
2022 (Docket No. FDA-2022-P-0558), under 21 CFR 10.30, requesting that
the Agency determine whether Oxandrin (oxandrolone) tablets, 2.5 mg and
10 mg, were withdrawn from sale for reasons of safety or effectiveness.
The petitioner has identified no data or other information suggesting
that Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg,
[[Page 62800]]
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 Oxandrin (oxandrolone) tablets, 2.5 mg and 10
mg, were withdrawn for reasons of safety or effectiveness. We have
carefully reviewed our files for records concerning the withdrawal of
Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, from sale. We have
also independently evaluated relevant literature and data for possible
postmarketing adverse events.
Our records show that FDA's Endocrinologic and Metabolic Drugs
Advisory Committee met and discussed anabolic steroids in January 1984.
The advisory committee unanimously concluded that there was no evidence
of efficacy for oxandrolone.\2\
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\2\ See minutes from the January 24 to 25, 1984, advisory
committee meeting discussing anabolic steroids, at pg. 7.
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As communicated in the product labeling for Oxandrin (oxandrolone)
tablets, 2.5 mg and 10 mg, multiple safety warnings and precautions are
associated with the use of this product 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 product 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\ Considering the safety concerns associated with the use of
oxandrolone noted in the labeling, the Agency concluded that the
benefit-risk profile of the drug product is unfavorable without
substantial evidence to support effectiveness.
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\3\ See footnote 1.
\4\ See footnote 1.
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Based on a thorough evaluation of the information we have available
to us and an evaluation of the latest version of the drug products'
approved labeling, we have determined that the drug products would not
be considered safe and effective if they were reintroduced to the
market today. New clinical studies would first need to be conducted to
address the concerns described above. Thus, 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 Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, were
withdrawn for reasons of safety or effectiveness. Accordingly, the
Agency will remove Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg,
from the list of drug products published in the Orange Book per Sec.
314.162. FDA will not accept or approve ANDAs that refer to this drug
product.
Dated: September 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19796 Filed 9-12-23; 8:45 am]
BILLING CODE 4164-01-P
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