[Federal Register Volume 73, Number 242 (Tuesday, December 16, 2008)]
[Notices]
[Page 76366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-29688]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0365] (formerly Docket No. 2007D-0117)


Guidance for Industry on Orally Disintegrating Tablets; 
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 guidance for industry entitled ``Orally 
Disintegrating Tablets.'' The guidance provides pharmaceutical 
manufacturers of new and generic products with an agency perspective on 
the definition of an orally disintegrating tablet (ODT) and also 
provides recommendations to applicants who would like to designate 
proposed products as ODTs.

DATES:  Submit written or electronic comments on agency guidances at 
any time.

ADDRESSES:  Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist that office in processing your requests. 
Submit written comments on the guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:  Frank O. Holcombe, Jr., Center for 
Drug Evaluation and Research (HFD-600), Food and Drug Administration, 
7500 Standish Pl., Rockville, MD 20855, 240-276-9310.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Orally Disintegrating Tablets.'' The guidance provides 
pharmaceutical manufacturers of new and generic drug products with an 
agency perspective on the definition of an ODT and also provides 
recommendations to applicants who would like to designate proposed 
products as ODTs.
    On April 9, 2007 (72 FR 17563), FDA announced the availability of 
the draft version of this guidance. The public comment period closed on 
June 8, 2007. The draft guidance also was discussed at an Advisory 
Committee for Pharmaceutical Science meeting held on July 22 and 23, 
2008. A number of comments were received from the public and during the 
meeting, all of which the agency considered carefully as it finalized 
the guidance and made appropriate changes. Any changes to the guidance 
were minor and made to clarify statements in the draft guidance.
    In an effort to develop drug products that are more convenient to 
use and to address potential issues of patient compliance for certain 
product indications and patient populations, pharmaceutical 
manufacturers have developed products that can be ingested simply by 
placing them on the tongue. The products are designed to disintegrate 
or dissolve rapidly on contact with saliva, thus eliminating the need 
to chew the tablet, swallow an intact tablet, or take the tablet with 
liquids. This mode of administration was initially expected to be 
beneficial to pediatric and geriatric patients, to people with 
conditions related to impaired swallowing, and for treatment of 
patients when compliance may be difficult (e.g., for psychiatric 
disorders).
    As firms started developing additional products using different 
technology and formulations, many of these later products exhibited 
wide variation in product characteristics from the initial products. 
Because this shift in product characteristics can affect suitability 
for particular uses, the agency developed this guidance for industry.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on orally disintegrating tablets. 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 statutes and 
regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.regulations.gov.

    Dated: December 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29688 Filed 12-15-08; 8:45 am]
BILLING CODE 4160-01-S