[Federal Register Volume 84, Number 30 (Wednesday, February 13, 2019)]
[Notices]
[Pages 3796-3797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02139]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-P-3597]


Determination That LOTRIMIN (Clotrimazole) Topical Solution, 1%, 
Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 LOTRIMIN (clotrimazole) topical solution, 1%, 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withdrawn from sale for reasons of safety or effectiveness.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: Stacy Kane, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products under an ANDA procedure. ANDA applicants 
must, with certain exceptions, show that the drug for which they are 
seeking approval contains the same active ingredient in the same 
strength and dosage form as the ``listed drug,'' which is a version of 
the drug that was previously approved. ANDA applicants do not have to 
repeat the extensive clinical testing otherwise necessary to gain 
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which 
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.
    LOTRIMIN (clotrimazole) topical solution, 1%, is the subject of NDA 
017613, held by Schering-Plough Healthcare Products Inc., and initially 
approved on February 3, 1975. LOTRIMIN is indicated for the topical 
treatment of candidiasis due to Candida albicans and tinea versicolor 
due to Malassezia furfur.
    LOTRIMIN (clotrimazole) topical solution, 1%, is currently listed 
in the ``Discontinued Drug Product List'' section of the Orange Book. 
In a letter dated August 31, 2005, Schering Corporation requested 
withdrawal of NDA 017613 for LOTRIMIN (clotrimazole). In the Federal 
Register of November 7, 2007 (72 FR 62858), FDA announced that it was 
withdrawing approval of NDA 017613, effective December 7, 2007.
    Arent Fox LLP submitted a citizen petition dated September 21, 2018 
(Docket No. FDA-2018-P-3597), under 21 CFR 10.30, requesting that the 
Agency determine whether LOTRIMIN (clotrimazole) topical solution, 1%, 
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 LOTRIMIN (clotrimazole) topical solution, 1%, 
was not withdrawn for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
LOTRIMIN (clotrimazole) topical solution, 1%, was withdrawn for reasons 
of safety or effectiveness. We have carefully reviewed our files for 
records concerning the withdrawal of LOTRIMIN (clotrimazole) topical 
solution, 1%, 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 LOTRIMIN 
(clotrimazole) topical solution, 1%, 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. In addition, FDA will 
continue to approve ANDAs for this drug product as long as they meet 
all other legal and regulatory requirements for the approval of ANDAs. 
If the Agency determines that labeling for this drug product should be 
revised to meet

[[Page 3797]]

current standards, the Agency will advise ANDA applicants to submit 
such labeling.

    Dated: February 8, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02139 Filed 2-12-19; 8:45 am]
 BILLING CODE 4164-01-P