[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]
-----------------------------------------------------------------------
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Draft Guidance for Industry on Labeling of OTC Topical Drug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.
-----------------------------------------------------------------------
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availability of a draft guidance for industry entitled ``Labeling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 The draft
guidance provides recommendations for both the carton and the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DATES: Written comments on the draft guidance may be submitted by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ADDRESSES: Copies of this draft guidance are available on the Internet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requests for single copies of the draft guidance entitled ``Labeling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 Submit written comments on the draft guidance to the Dockets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draft guidance for industry entitled ``Labeling Guidance for OTC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
