[Federal Register Volume 89, Number 52 (Friday, March 15, 2024)]
[Notices]
[Pages 18946-18947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05582]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-P-4065]
Determination That NUCYNTA (Tapentadol Hydrochloride) Solution,
Equivalent 20 Milligrams Base/Milliliter, Was Not Withdrawn From Sale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 or Agency) has
determined that NUCYNTA (tapentadol hydrochloride) solution, equivalent
(eq) 20 milligrams (mg) base/milliliter (mL), was not withdrawn from
sale for reasons of safety or effectiveness. This determination will
allow FDA to approve abbreviated new drug applications (ANDAs) for
tapentadol hydrochloride solution, eq 20 mg base/mL, if all other legal
and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Kaetochi Okemgbo, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6624, Silver Spring, MD 20993-0002, 301-
796-1546, [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 Sec. 314.162 (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.
NUCYNTA (tapentadol hydrochloride) solution, eq 20 mg base/mL, is
the subject of NDA 203794, held by Collegium Pharmaceutical, Inc., and
initially approved on October 15, 2012. NUCYNTA is indicated for the
management of acute pain severe enough to require an opioid analgesic
and for which alternative treatments are inadequate in adults and
pediatric patients aged 6 years and older with a body weight of at
least 16 kilograms.
Collegium Pharmaceutical, Inc. has never marketed NUCYNTA
(tapentadol hydrochloride) solution, eq 20 mg base/mL. In previous
instances (see, e.g., 72 FR 9763, March 5, 2007; 61 FR 25497, May 21,
1996, the Agency has determined that, for purposes of Sec. Sec.
314.161 and 314.162, never marketing an approved drug product is
equivalent to withdrawing the drug from sale.
Novitium Pharma, LLC submitted a citizen petition dated September
19, 2023 (Docket No. FDA-2023-P-4065), under 21 CFR 10.30, requesting
that the Agency determine whether NUCYNTA (tapentadol hydrochloride)
solution, eq 20 mg base/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 Sec. 314.161 that NUCYNTA (tapentadol hydrochloride) solution,
eq 20 mg base/mL, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that NUCYNTA (tapentadol hydrochloride)
solution, eq 20 mg base/mL, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of NUCYNTA (tapentadol hydrochloride)
solution, eq 20 mg base/mL, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have reviewed the available evidence and
[[Page 18947]]
determined that this drug product was not withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will continue to list NUCYNTA (tapentadol
hydrochloride) solution, eq 20 mg base/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. ANDAs that refer to NUCYNTA (tapentadol hydrochloride)
solution, eq 20 mg base/mL, 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 this drug product should
be revised to meet current standards, the Agency will advise ANDA
applicants to submit such labeling.
Dated: March 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05582 Filed 3-14-24; 8:45 am]
BILLING CODE 4164-01-P