[Federal Register Volume 89, Number 161 (Tuesday, August 20, 2024)]
[Notices]
[Pages 67447-67448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-18615]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-P-2220]


Determination That PENNSAID (Diclofenac Sodium) Topical Solution 
2%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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, Agency, or we) has 
determined that PENNSAID (diclofenac sodium) Topical Solution 2%, was 
not withdrawn from sale for reasons of safety or effectiveness.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 
this drug product, and it will allow FDA to continue to approve ANDAs 
that refer to the product as long as they meet relevant legal and 
regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Awo Archampong-Gray, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6243, Silver Spring, MD 20993-0002, 301-
796-0110, [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

[[Page 67448]]

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.
    PENNSAID (diclofenac sodium) Topical Solution 2%, is the subject of 
NDA 204623, held by Horizon Therapeutics Ireland DAC, and initially 
approved on January 16, 2014. PENNSAID is a nonsteroidal anti-
inflammatory drug indicated for the treatment of the pain of 
osteoarthritis of the knees. PENNSAID (diclofenac sodium) Topical 
Solution 2%, is currently listed in the ``Discontinued Drug Product 
List'' section of the Orange Book.
    Encube Ethicals Private Limited submitted a citizen petition dated 
May 6, 2024 (Docket No. FDA-2024-P-2220), under 21 CFR 10.30, 
requesting that the Agency determine whether PENNSAID (diclofenac 
sodium) Topical Solution 2%, 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 PENNSAID (diclofenac sodium) Topical Solution 
2%, was not withdrawn for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
PENNSAID (diclofenac sodium) Topical Solution 2%, was withdrawn for 
reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of PENNSAID (diclofenac 
sodium) Topical Solution 2%, 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 
this drug product was withdrawn from sale for reasons of safety or 
effectiveness.
    Accordingly, the Agency will continue to list PENNSAID (diclofenac 
sodium) Topical Solution 2%, 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. FDA will not begin procedures to withdraw approval of 
approved ANDAs that refer to this drug product. Additional ANDAs for 
this drug product may also 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: August 15, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-18615 Filed 8-19-24; 8:45 am]
BILLING CODE 4164-01-P