Notice2023-11162
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and 30 Milliliter Vials and 7.5 Milligrams (Base)/Milliliter, 10 Milliliter and 30 Milliliter Vials, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 25, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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10 mL and 30 mL vials, 5 mg (base)/mL, 10 mL and 30 mL vials and 7.5 mg (base)/mL, 10 mL and 30 mL vials, were not withdrawn from sale for reasons of safety or effectiveness.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.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 101 (Thursday, May 25, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 101 (Thursday, May 25, 2023)]
[Notices]
[Pages 33888-33889]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-11162]
-----------------------------------------------------------------------
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Vials, Were Not Withdrawn From Sale for Reasons of Safety or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.
-----------------------------------------------------------------------
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,
<a href="/cdn-cgi/l/email-protection#4c082322222d62183e2d220c2a282d6224243f622b233a"><span class="__cf_email__" data-cfemail="7b3f1415151a552f091a153b1d1f1a55131308551c140d">[email protected]</span></a>.
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on May 25, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.