[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]


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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.

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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DATES: Approval is withdrawn as of June 28, 2023.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.

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     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.
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    \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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    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\
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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, 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\
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    \3\ See OXANDRIN (oxandrolone) tablets, NDA 013718, product 
labeling, (rev. June 2005).
    \4\ Id.
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    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