[Federal Register Volume 88, Number 176 (Wednesday, September 13, 2023)]
[Notices]
[Pages 62799-62800]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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and 10 Milligrams, Were Withdrawn From Sale for Reasons of Safety or 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10 mg, were withdrawn from sale for reasons of safety or effectiveness.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, [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FDA determines that the listed drug was withdrawn from sale for reasons 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 (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 
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013718s023lbl.pdf.
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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