[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]


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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Equivalent 20 Milligrams Base/Milliliter, Was Not Withdrawn From Sale 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.

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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(eq) 20 milligrams (mg) base/milliliter (mL), was not withdrawn from 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