Federal Register / Vol. 88, No. 224 / Wednesday, November 22, 2023 / Notices 81419 

Dated: November 17, 2023. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–25861 Filed 11–21–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–P–4223] 

Determination That BUPRENEX 

(Buprenorphine Hydrochloride) 

Injection, 0.3 Milligram/Milliliter, Was 

Not Withdrawn From Sale for Reasons 

of Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) has determined that BUPRENEX 

(buprenorphine hydrochloride) 

Injection, 0.3 milligram (mg)/milliliter 

(mL), was not withdrawn from sale for 

reasons of safety or effectiveness. This 

determination means that FDA will not 

begin procedures to withdraw approval 

of abbreviated new drug applications 

(ANDAs) that refer to this drug product, 

and it will allow FDA to continue to 

approve ANDAs that refer to the 

product as long as they meet relevant 

legal and regulatory requirements. 

FOR FURTHER INFORMATION CONTACT: 

Caitlin Callahan, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6269, 

Silver Spring, MD 20993–0002, 301– 

796–3600, Caitlin.Callahan@

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 (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. 

BUPRENEX (buprenorphine 

hydrochloride) Injection, 0.3 mg/mL, is 

the subject of NDA 018401, held by 

Indivior, Inc., and initially approved on 

December 29, 1981. BUPRENEX is 

indicated for the management of pain 

severe enough to require an opioid 

analgesic and for which alternate 

treatments are inadequate. 

BUPRENEX (buprenorphine 

hydrochloride) Injection, 0.3 mg/mL, is 

currently listed in the ‘‘Discontinued 

Drug Product List’’ section of the Orange 

Book. Odin Pharmaceuticals LLC 

submitted a citizen petition dated 

September 27, 2023 (Docket No. FDA– 

2023–P–4223), under 21 CFR 10.30, 

requesting that the Agency determine 

whether BUPRENEX (buprenorphine 

hydrochloride) Injection, 0.3 mg/mL, 

was 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 BUPRENEX 

(buprenorphine hydrochloride) 

Injection, 0.3 mg/mL, was not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that this drug product was 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 

BUPRENEX (buprenorphine 

hydrochloride) Injection, 0.3 mg/mL, 

from sale. We have also independently 

evaluated relevant literature and data 

for possible postmarketing adverse 

events. We have found no information 

that would indicate that this drug 

product was withdrawn from sale for 

reasons of safety or effectiveness. 

Accordingly, the Agency will 

continue to list BUPRENEX 

(buprenorphine hydrochloride) 

Injection, 0.3 mg/mL, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. FDA will not 

begin procedures to withdraw approval 

of approved ANDAs that refer to this 

drug product. Additional ANDAs for 

this drug product may also be approved 

by the Agency as long as they meet all 

other legal and regulatory requirements 

for the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: November 17, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–25857 Filed 11–21–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–4719] 

Translation of Good Laboratory 

Practice Study Reports: Questions and 

Answers; Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Translation of GLP Study Reports: 

Questions and Answers.’’ This guidance 

provides information to sponsors and 

nonclinical laboratories regarding the 

translation of study reports for studies 

conducted in compliance with good 

laboratory practice (GLP) regulations. 

GLP studies are nonclinical safety 

studies that include, but are not limited 

to nonclinical toxicology studies, safety 

pharmacology studies, and device safety 

studies. When study reports of GLP 

studies are translated from the original 

language into English, adequate 

documentation is critical to ensure 


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