[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Withdrawn From Sale for Reasons of Safety or Effectiveness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milligrams (mg)/10 milliliters (mL) and 75mg/10mL, were not withdrawn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