Federal Register / Vol. 88, No. 176 / Wednesday, September 13, 2023 / Notices 62799 

1See 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. 

ESTIMATED RECORDKEEPING TIME

Instrument Respondent Total number 

of respondents 

Total number 

of responses 

per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Annual burden 

hours 

SMR Form ..... Care Provider Program Staff ................... 250 1.38 .08 27.6 9 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: 6 U.S.C 279: Exhibit 1, part 

A.2 of the Flores Settlement Agreement 

(Jenny Lisette Flores, et al., v. Janet 

Reno, Attorney General of the United 

States, et al., Case No. CV 85–4544–RJK 

[C.D. Cal. 1996]) 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2023–19795 Filed 9–12–23; 8:45 am] 

BILLING CODE 4184–45–P 

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and 10 Milligrams, Were Withdrawn 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. 

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(mg) and 10 mg, were withdrawn from 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, Alexandria.Fujisaki@

fda.hhs.gov. 

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 

(§ 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 (§ 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

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 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 § 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 § 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 § 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, 


ddrumheller on DSK120RN23PROD with NOTICES1
62800 Federal Register / Vol. 88, No. 176 / Wednesday, September 13, 2023 / Notices 

2See minutes from the January 24 to 25, 1984, 

advisory committee meeting discussing anabolic 

steroids, at pg. 7. 

3See footnote 1. 

4See footnote 1. 

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 

§ 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

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 intraabdominal 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. 

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 

§ 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 § 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Findings of Research Misconduct 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: Findings of research 

misconduct have been made against 

Kotha Subbaramaiah, Ph.D. 

(Respondent), who was a Professor of 

Biochemistry Research in Medicine, 

Department of Medicine, Weill Cornell 

Medical College (WCMC). Respondent 

engaged in research misconduct in 

research supported by U.S. Public 

Health Service (PHS) funds, specifically 

National Cancer Institute (NCI), 

National Institutes of Health (NIH), 

grants P01 CA077839, P01 CA106451, 

R01 CA108773, R01 CA154481, T32 

CA009685, R25 CA105012, and N01 

CN43302, National Institute on Deafness 

and Other Communication Disorders 

(NIDCD), NIH, grant T32 DC000027, and 

National Center for Advancing 

Translational Sciences (NCATS), NIH, 

grant UL1 TR000457. The 

administrative actions, including 

debarment for a period of seven (7) 

years, were implemented beginning on 

August 16, 2023, and are detailed 

below. 

FOR FURTHER INFORMATION CONTACT: 

Sheila Garrity, JD, MPH, MBA, Director, 

Office of Research Integrity, 1101 

Wootton Parkway, Suite 240, Rockville, 

MD 20852, (240) 453–8200. 

SUPPLEMENTARY INFORMATION: Notice is 

hereby given that the Office of Research 

Integrity (ORI) has taken final action in 

the following case: 

Kotha Subbaramaiah, Ph.D., Weill 

Cornell Medical College: Based on the 

report of an investigation conducted by 

WCMC and additional analysis 

conducted by ORI in its oversight 

review, ORI found that Kotha 

Subbaramaiah, Ph.D., former Weill 

Cornell Medical College, WCMC, 

engaged in research misconduct in 

research supported by PHS funds, 

specifically NCI, NIH, grants P01 

CA077839, P01 CA106451, R01 

CA108773, R01 CA154481, T32 

CA009685, R25 CA105012, and N01 

CN43302, NIDCD, NIH, grant T32 

DC000027, and NCATS, NIH, grant UL1 

TR000457. 

ORI found that Respondent engaged 

in research misconduct by intentionally, 

knowingly, or recklessly falsifying and/ 

or fabricating data included in the 

following twelve (12) published papers: 

• Increased levels of COX–2 and 

prostaglandin E2 contribute to elevated 

aromatase expression in inflamed breast 

tissue of obese women. Cancer Discov. 

2012 Apr;2(4):356–65. doi: 10.1158/ 

2159–8290.CD–11–0241 (hereafter 

referred to as ‘‘Cancer Discov. 2012’’). 

Retraction in: Cancer Discov. 2021 

May;11(5):1306. doi: 10.1158/2159– 

8290.CD–21–0224. 

• EP2 and EP4 receptors regulate 

aromatase expression in human 

adipocytes and breast cancer cells. 

Evidence of a BRCA1 and p300 

exchange. J Biol Chem. 2008 Feb 

8;283(6):3433–44. doi: 10.1074/ 

jbc.M705409200 (hereafter referred to as 

‘‘J Biol Chem. 2008’’). Retraction in: J 

Biol Chem. 2020 Jan 3; 295(1):295. doi: 

10.1074/jbc.W119.012140. 

• HDAC6 modulates Hsp90 

chaperone activity and regulates 

activation of aryl hydrocarbon receptor 

signaling. J Biol Chem. 2009 Mar 20; 

284(12):7436–45. doi: 10.1074/ 

jbc.M808999200 (hereafter referred to as 

‘‘J Biol Chem. 2009’’). Retraction in: J 

Biol Chem. 2020 Jan 3; 295(1):297. doi: 

10.1074/jbc.W119.012142. 

• p53 protein regulates Hsp90 

ATPase activity and thereby Wnt 

signaling by modulating Aha1 

expression. J Biol Chem. 2014 Mar 

7;289(10):6513–25. doi: 10.1074/ 

jbc.M113.532523 (hereafter referred to 

as ‘‘J Biol Chem. 2014’’). Retraction in: 

J Biol Chem. 2020 Jan 3; 295(1):289. doi: 

10.1074/jbc.W119.012134. 

• Hsp90 and PKM2 drive the 

expression of aromatase in Li-Fraumeni 

syndrome breast adipose stromal cells. J 

Biol Chem. 2016 Jul 29;291(31):16011– 

23. doi: 10.1074/jbc.M115.698902 

(hereafter referred to as ‘‘J Biol Chem. 

2016’’). Retraction in: J Biol Chem. 2020 

Jan 3; 295(1):290. doi: 10.1074/ 

jbc.W119.012135. 

• Heat shock protein 90 inhibitors 

suppress aryl hydrocarbon receptormediated activation of CYP1A1 and 

CYP1B1 transcription and DNA adduct 

formation. Cancer Prev Res (Phila). 2008 


ddrumheller on DSK120RN23PROD with NOTICES1