Document ID: FDA-2021-P-1323-0003
Agency: fda
Document Type: Notice
Title: Determination That NAROPIN Ropivacaine Hydrochloride) Solution, 50 Milligrams/10 Milliliters and 75 Milligrams/10 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Posted Date: 2023-10-18T04:00Z

[Federal Register Volume 88, Number 200 (Wednesday, October 18, 2023)]
[Notices]
[Pages 71871-71872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22960]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-P-1323]

Determination That NAROPIN (Ropivacaine Hydrochloride) Solution, 
50 Milligrams/10 Milliliters and 75 Milligrams/10 Milliliters, 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Withdrawn From Sale for Reasons of Safety or Effectiveness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, Agency, or we) has 
determined that Naropin (ropivacaine hydrochloride) solution, 50 
milligrams (mg)/10 milliliters (mL) and 75mg/10mL, were not withdrawn 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 these drug 
products, and it will allow FDA to continue to approve ANDAs that refer 
to these drug products as long as they meet relevant legal and 
regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Alexander Poonai, 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 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.
    Naropin (ropivacaine hydrochloride) solution, 50mg/10mL and 75mg/
10mL, are the subject of NDA 020533, held by Fresenius Kabi USA LLC, 
and initially approved on May 1, 1998. Naropin is indicated for the 
production of local or regional anesthesia for surgery and for acute 
pain management.
    Naropin (ropivacaine hydrochloride) solution, 50mg/10mL and 75mg/
10mL, are currently listed in the ``Discontinued Drug Product List'' 
section of the Orange Book.
    Lachman Consultant Services, Inc., submitted a citizen petition 
dated December 15, 2021 (Docket No. FDA-2021-P-1323), under 21 CFR 
10.30, requesting that the Agency determine whether Naropin 
(ropivacaine hydrochloride) solution, 50mg/10mL and 75mg/10mL, 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 Sec.  314.161 that Naropin (ropivacaine hydrochloride) solution, 
50mg/10mL and 75mg/10mL, were not withdrawn for reasons of safety or 
effectiveness. The petitioner has identified no data or other 
information suggesting that these drug products were withdrawn for 
reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of Naropin (ropivacaine 
hydrochloride) solution, 50mg/10mL and 75mg/10mL, from sale. We have 
also independently

[[Page 71872]]

evaluated relevant literature and data for possible postmarketing 
adverse events. We have reviewed the available evidence and determined 
that these drug products were not withdrawn from sale for reasons of 
safety or effectiveness.
    Accordingly, the Agency will continue to list Naropin (ropivacaine 
hydrochloride) solution, 50mg/10mL and 75mg/10mL, 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 Naropin (ropivacaine hydrochloride) 
solution, 50mg/10mL and 75mg/10mL, 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: October 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22960 Filed 10-17-23; 8:45 am]
BILLING CODE 4164-01-P