Determination That Oxandrin (Oxandrolone) Tablets, 2.5 Milligrams and 10 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effectiveness; Correction

Issuing agencies

Abstract

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of September 13, 2023 (88 FR 62799). The notice announced the determination that Oxandrin (oxandrolone) tablets, 2.5 milligrams (mg) and 10 mg, were withdrawn from sale for reasons of safety or effectiveness. The notice did not include the determination that the abbreviated new drug applications (ANDAs) referencing Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, were also determined to be withdrawn from sale for reasons of safety or effectiveness and that these ANDAs would be removed from "Approved Drug Products With Therapeutic Equivalence Evaluations," which is known generally as the "Orange Book." This notice corrects that error.

Full Text

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<title>Federal Register, Volume 91 Issue 193 (Wednesday, October 7, 2026)</title>
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[Federal Register Volume 91, Number 193 (Wednesday, October 7, 2026)]
[Notices]
[Pages 64154-64155]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20503]


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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and 10 Milligrams, Were Withdrawn From Sale for Reasons of Safety or 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; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of September 13, 2023 (88 FR 
62799). The notice announced the determination that Oxandrin 
(oxandrolone) tablets, 2.5 milligrams (mg) and 10 mg, were withdrawn 
from sale for reasons of safety or effectiveness. The notice did not 
include the determination that the abbreviated new drug applications 
(ANDAs) referencing Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, 
were also determined to be withdrawn from sale for reasons of safety or 
effectiveness and that these ANDAs would be removed from ``Approved 
Drug Products With Therapeutic Equivalence Evaluations,'' which is 
known generally as the ``Orange Book.'' This notice corrects that 
error.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993-0002, 301-
796-3137, <a href="/cdn-cgi/l/email-protection#abe0c2c6c9ced9c7d285e7cec3d9cdcec7cfebcdcfca85c3c3d885ccc4dd"><span class="__cf_email__" data-cfemail="fcb795919e998e9085d2b099948e9a999098bc9a989dd294948fd29b938a">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 13, 
2023, appearing on pages 62799 and 62800 in FR Doc. 2023-19796, the 
following corrections are made:
    1. On page 62799, in the first column, before the last sentence in 
the SUMMARY section, the following sentence is added:
    Additionally, FDA has determined that Par Pharmaceutical Inc.'s 
ANDA 077827 for oxandrolone tablets, 2.5 mg and 10 mg; Roxane 
Laboratories, Inc.'s ANDA 077249 for oxandrolone tablets, 2.5 mg and 10 
mg; Sandoz Inc.'s ANDA 076897 for oxandrolone tablets, 2.5 mg and 10 
mg; and Upsher Smith Laboratories LLC's ANDA 076761 for oxandrolone 
tablet, 2.5 mg, and ANDA 078033 for oxandrolone tablet, 10 mg, that all 
reference Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, were also 
withdrawn for reasons of safety or effectiveness.
    2. On page 62799 in the third column, the second paragraph is 
corrected to read as follows:
    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 
for oxandrolone tablets, 2.5 mg and 10 mg, 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). After FDA notified Gemini that it believes the potential 
problems associated with the drugs are sufficiently serious that the 
drugs 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). Similarly, after notification by FDA, 
the following holders of approved ANDAs requested withdrawal of their 
applications under Sec.  314.150(d) and waived their opportunity for a 
hearing: Par Pharmaceutical Inc. for ANDA 077827 for oxandrolone 
tablets, 2.5 mg and 10 mg; Sandoz Inc. for ANDA 076897 for oxandrolone 
tablets, 2.5 mg and 10 mg; and Upsher Smith Laboratories LLC for ANDA 
076761 for oxandrolone tablet, 2.5 mg, and ANDA 078033 for oxandrolone 
tablet, 10 mg. In the Federal Register of June 28, 2023 (88 FR 41970), 
FDA announced that it was withdrawing approval of NDA 013718, ANDA 
077827, ANDA 076897, ANDA 076761, and ANDA 078033, effective June 28, 
2023. Additionally, Roxane Laboratories, Inc. previously requested 
withdrawal of its ANDA 077249 for oxandrolone tablets, 2.5 mg and 10 
mg, and waived its opportunity for a hearing. In the Federal Register 
of May 19, 2009 (74 FR 23407), FDA announced that it was withdrawing 
approval of ANDA 077249, effective June 18, 2009.

[[Page 64155]]

    3. On page 62800 at the top of the second column, at the end of the 
first paragraph, the following two sentences are added:
    Likewise, FDA has determined under Sec.  314.161 that those ANDAs 
that used Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, approved in 
NDA 013718 as their reference listed drug were withdrawn for reasons of 
safety or effectiveness. Accordingly, the Agency will remove Par 
Pharmaceutical Inc.'s ANDA 077827 for oxandrolone tablets, 2.5 mg and 
10 mg; Roxane Laboratories, Inc.'s ANDA 077249 for oxandrolone tablets, 
2.5 mg and 10 mg; Sandoz Inc.'s ANDA 076897 for oxandrolone tablets, 
2.5 mg and 10 mg; and Upsher Smith Laboratories LLC's ANDA 076761 for 
oxandrolone tablet, 2.5 mg, and ANDA 078033 for oxandrolone tablet, 10 
mg, from the list of drug products published in the Orange Book per 
Sec.  314.162.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-20503 Filed 10-6-26; 8:45 am]
BILLING CODE 4164-01-P


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