[Federal Register Volume 63, Number 136 (Thursday, July 16, 1998)]
[Notices]
[Pages 38412-38413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18879]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0469]


Draft Guidance for Industry on Labeling of OTC Topical Drug 
Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal 
Candidiasis); Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Labeling 
Guidance for OTC Topical Drug Products for the Treatment of Vaginal 
Yeast Infections (Vulvovaginal Candidiasis).'' The guidance is intended 
to provide a general labeling format for all over-the-counter (OTC) 
drug products for the treatment of vaginal yeast infections. The draft 
guidance provides recommendations for both the carton and the 
educational brochure.

DATES:  Written comments on the draft guidance may be submitted by 
October 14, 1998. General comments on the agency guidances are welcome 
at any time.

ADDRESSES:  Copies of this draft guidance are available on the Internet 
at ``http://www.fda.gov/cder/guidance/index.htm.'' Submit written 
requests for single copies of the draft guidance entitled ``Labeling 
Guidance for OTC Topical Drug Products for the Treatment of Vaginal 
Yeast Infections (Vulvovaginal Candidiasis)'' to the Drug Information 
Branch (HFD-210), Center for Drug Evaluation and Research, Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one 
self-addressed adhesive label to assist that office in processing your 
request. Submit written comments on the draft guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Requests and comments are to be 
identified with the docket number found in brackets in the heading of 
this document.
FOR FURTHER INFORMATION CONTACT:  Cheryl A. Turner, Center for Drug 
Evaluation and Research (HFD-560), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2222.

SUPPLEMENTARY INFORMATION:  FDA is announcing the availability of a 
draft guidance for industry entitled ``Labeling Guidance for OTC 
Topical Drug Products for the Treatment of Vaginal Yeast Infections 
(Vulvovaginal Candidiasis).'' Current labeling for such OTC drug 
products varies widely among manufacturers. However, the content to be 
communicated in labeling is nearly identical for each product; thus the 
labeling for these products should convey a clear and consistent 
message for the consumer. The intent of this document is to provide 
labeling guidance for all OTC drug products to treat vaginal yeast 
infections.
    Until 1990, topical drug products for the treatment of vulvovaginal 
candidiasis were available by prescription only. In 1990, FDA convened 
an advisory committee

[[Page 38413]]

meeting to obtain expert on opinion whether the agency should allow 
topical therapies to be made available for OTC use. The advisory 
committee recommended that women whose initial episode of vulvovaginal 
candidiasis was diagnosed and treated by a physician could adequately 
self-treat their condition without the supervision of a health care 
provider. The first 7-day intravaginal drug product for the treatment 
of vulvovaginal candidiasis was approved for OTC use in 1990; the first 
3-day product in 1995; and the first single-dose product in 1997.
    In the Federal Register of February 27, 1997 (62 FR 9024), the 
agency published a notice entitled ``Over-the-Counter Human Drugs; 
Proposed Labeling Requirements,'' proposing a standardized format for 
the labeling of OTC drug products. This proposed standardized format is 
frequently referred to as the ``Drug Facts Format.'' The agency is 
developing this guidance document on labeling for OTC drug products for 
the treatment of vaginal yeast infections in accordance with the ``Drug 
Facts Format.''
    Labeling for OTC drug products for the treatment of vaginal yeast 
infections consists of three components: (1) The carton, (2) the 
educational brochure, and (3) the overwrap. With OTC drug products, the 
agency believes that labeling takes on the critical role of providing 
information to the consumer. Therefore, consumers must have information 
that is easily understood to allow for appropriate self-selection and 
appropriate use of the product. Since there are a variety of OTC 
products currently available for the treatment of vaginal yeast 
infections, and since in most cases, the content to be communicated in 
labeling is nearly identical for each product, the labeling for these 
products should convey a clear and consistent message to the consumer. 
The intent of the draft guidance is to provide labeling guidance for 
all OTC drug products for the treatment of vaginal yeast infections.
    The draft guidance represents the agency's current thinking on the 
labeling of OTC topical drug products for the treatment of vaginal 
yeast infections. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statute, regulations, or both.
    Interested persons may, on or before October 14, 1998, submit 
written comments on the draft guidance to the Dockets Management Branch 
(address above). Two copies of any comments are to be submitted, except 
that individuals may submit one copy. The draft guidance document and 
received comments are available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 7, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-18879 Filed 7-15-98; 8:45 am]
BILLING CODE 4160-01-F