[Federal Register Volume 88, Number 101 (Thursday, May 25, 2023)]
[Notices]
[Pages 33888-33889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11162]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-P-3293]


Determination That Chirocaine (Levobupivacaine) Injection, 2.5 
Milligrams (Base)/Milliliter, 10 Milliliter and 30 Milliliter Vials, 5 
Milligrams (Base)/Milliliter, 10 Milliliter and 30 Milliliter Vials and 
7.5 Milligrams (Base)/Milliliter, 10 Milliliter and 30 Milliliter 
Vials, Were Not Withdrawn From Sale for Reasons of Safety or 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 or Agency) has 
determined that Chirocaine (levobupivacaine) injection, 2.5 milligrams 
(mg) (base)/milliliter (mL), 10 mL and 30 mL vials, 5 mg (base)/mL, 10 
mL and 30 mL vials and 7.5 mg (base)/mL, 10 mL and 30 mL vials, were 
not withdrawn from sale for reasons of safety or effectiveness. This 
determination will allow FDA to approve abbreviated new drug 
applications (ANDAs) for levobupivacaine injection, 2.5 milligrams (mg) 
(base)/milliliter (mL), 10 mL and 30 mL vials, 5 mg (base)/mL, 10 mL 
and 30 mL vials and 7.5 mg (base)/mL, 10 mL and 30 mL vials, if all 
other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Donna Tran, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6213, 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

[[Page 33889]]

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 (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that 
does not refer to a listed drug.
    Chirocaine (levobupivacaine) injection, 2.5 mg (base)/mL, 10 mL and 
30 mL vials, 5 mg (base)/mL, 10 mL and 30 mL vials and 7.5 mg (base)/
mL, 10 mL and 30 mL vials, is the subject of NDA 020997, held by Purdue 
Pharma L.P., and initially approved on August 5, 1999. Chirocaine is 
indicated to produce local or regional anesthesia for surgery and 
obstetrics, and for post-operative pain management.
    In a letter dated May 21, 2004, Purdue Pharma L.P. requested 
withdrawal of NDA 020997 for Chirocaine (levobupivacaine) injection, 
2.5 mg (base)/mL, 10 mL and 30 mL vials, 5 mg (base)/mL, 10 mL and 30 
mL vials and 7.5 mg (base)/mL, 10 mL and 30 mL vials. In the Federal 
Register of March 4, 2005 (70 FR 10651), FDA announced that it was 
withdrawing approval of NDA 020997, effective April 4, 2005. Chirocaine 
is currently listed in the ``Discontinued Drug Product List'' section 
of the Orange Book.
    Lachman Consultant Services, Inc. submitted a citizen petition 
dated December 21, 2022 (Docket No. FDA-2022-P-3293), under 21 CFR 
10.30, requesting that the Agency determine whether Chirocaine 
(levobupivacaine) injection, 2.5 mg (base)/mL, 10 mL and 30 mL vials, 5 
mg (base)/mL, 10 mL and 30 mL vials and 7.5 mg (base)/mL, 10 mL and 30 
mL vials, were withdrawn from sale for reasons of safety or efficacy.
    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 Chirocaine (levobupivacaine) injection, 2.5 mg 
(base)/mL, 10 mL and 30 mL vials, 5 mg (base)/mL, 10 mL and 30 mL vials 
and 7.5 mg (base)/mL, 10 mL and 30 mL vials, were not withdrawn for 
reasons of safety or effectiveness. The petitioner has identified no 
data or other information suggesting that Chirocaine (levobupivacaine) 
injection, 2.5 mg (base)/mL, 10 mL and 30 mL vials, 5 mg (base)/mL, 10 
mL and 30 mL vials and 7.5 mg (base)/mL, 10 mL and 30 mL vials, were 
withdrawn for reasons of safety or effectiveness.
    We have carefully reviewed our files for records concerning the 
withdrawal of Chirocaine (levobupivacaine) injection, 2.5 mg (base)/mL, 
10 mL and 30 mL vials, 5 mg (base)/mL, 10 mL and 30 mL vials and 7.5 mg 
(base)/mL, 10 mL and 30 mL vials, 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 
these drug products were withdrawn from sale for reasons of safety or 
effectiveness.
    Accordingly, the Agency will continue to list Chirocaine 
(levobupivacaine) injection, 2.5 mg (base)/mL, 10 mL and 30 mL vials, 5 
mg (base)/mL, 10 mL and 30 mL vials and 7.5 mg (base)/mL, 10 mL and 30 
mL vials, 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. ANDAs that refer to 
Chirocaine (levobupivacaine) injection, 2.5 mg (base)/mL, 10 mL and 30 
mL vials, 5 mg (base)/mL, 10 mL and 30 mL vials or 7.5 mg (base)/mL, 10 
mL and 30 mL vials, may 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 these drug products should be 
revised to meet current standards, the Agency will advise ANDA 
applicants to submit such labeling.

    Dated: May 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-11162 Filed 5-24-23; 8:45 am]
BILLING CODE 4164-01-P