Form Approved: OMB No. 0910-0001, Expiration Date: May 31, 2008, See OMB
Statement on Page 3.

<table>
<colgroup>
<col style="width: 16%" />
<col style="width: 17%" />
<col style="width: 1%" />
<col style="width: 7%" />
<col style="width: 7%" />
<col style="width: 0%" />
<col style="width: 13%" />
<col style="width: 16%" />
<col style="width: 6%" />
<col style="width: 13%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="4" rowspan="2"><strong>TRANSMITTAL OF ADVERTISEMENTS AND
PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS<br />
FOR HUMAN USE</strong></td>
<td colspan="3"><p>1. DATE SUBMITTED</p>
<blockquote>
<p>     </p>
</blockquote></td>
<td colspan="3" rowspan="2"><p>3. NDA/ANDA/AADA OR BLA/PLA/PMA</p>
<blockquote>
<p>Number:      </p>
<p>Single product Multiple products </p>
<p>For multiple products, submit completed form and specimen of
advertising/promotional materials to one application of choice and
attach separate sheet addressing items 3-5 for remainder of products.
Refer to No. 3 on instruction sheet.</p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="3"><p>2 LABEL REVIEW NO. <em>(Biologics)</em></p>
<blockquote>
<p>     </p>
</blockquote></td>
</tr>
<tr class="odd">
<td colspan="10"><strong>NOTE: Form 2253 is required by law. Reports are
required for approved NDAs and ANDAs (21 CFR 314.81)</strong></td>
</tr>
<tr class="even">
<td colspan="5"><p>4. PROPRIETARY NAME</p>
<blockquote>
<p>     </p>
</blockquote></td>
<td colspan="5"><p>5. ESTABLISHED NAME</p>
<blockquote>
<p>     </p>
<p>Prod. Code No.      </p>
</blockquote></td>
</tr>
<tr class="odd">
<td colspan="5"><p>6. PACKAGE INSERT DATE and ID NO</p>
<p><em>(Latest final printing labeling)</em></p>
<blockquote>
<p>     </p>
</blockquote></td>
<td colspan="5"><p>7. MANUFACTURER NAME:</p>
<blockquote>
<p>     </p>
<p>License No.      </p>
<p><em>(Biologics)</em></p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="10"><strong>FDA/CBER USE ONLY</strong></td>
</tr>
<tr class="odd">
<td colspan="3"><p>REVIEWED BY:</p>
<p>     </p></td>
<td colspan="2"><p>DATE</p>
<p>     </p></td>
<td colspan="4"><p>RETURNED BY:</p>
<p>     </p></td>
<td><p>DATE</p>
<p>     </p></td>
</tr>
<tr class="even">
<td colspan="10"><strong>8. ADVERTISMENT / PROMOTIONAL LABLEING
MATERIALS</strong></td>
</tr>
<tr class="odd">
<td colspan="10"><strong>Please check only one:</strong> Professional
Consumer</td>
</tr>
<tr class="even">
<td><p>Material Type<br />
(use FDA codes)</p>
<p>a.</p></td>
<td><p>Dissemination/<br />
Publication Date</p>
<p>b.</p></td>
<td colspan="5"><p>Applicant’s Material ID Code and/or description</p>
<p>c.</p></td>
<td>Previous review No.<br />
if applicable / date<br />
(PLA Submissions)<br />
d.</td>
<td colspan="2" rowspan="9"><p>COMMENTS:</p>
<p>     </p></td>
</tr>
<tr class="odd">
<td>     </td>
<td>     </td>
<td colspan="5">     </td>
<td>     </td>
</tr>
<tr class="even">
<td>     </td>
<td>     </td>
<td colspan="5">     </td>
<td>     </td>
</tr>
<tr class="odd">
<td>     </td>
<td>     </td>
<td colspan="5">     </td>
<td>     </td>
</tr>
<tr class="even">
<td>     </td>
<td>     </td>
<td colspan="5">     </td>
<td>     </td>
</tr>
<tr class="odd">
<td>     </td>
<td>     </td>
<td colspan="5">     </td>
<td>     </td>
</tr>
<tr class="even">
<td>     </td>
<td>     </td>
<td colspan="5">     </td>
<td>     </td>
</tr>
<tr class="odd">
<td>     </td>
<td>     </td>
<td colspan="5">     </td>
<td>     </td>
</tr>
<tr class="even">
<td>     </td>
<td>     </td>
<td colspan="5">     </td>
<td>     </td>
</tr>
<tr class="odd">
<td colspan="10"></td>
</tr>
<tr class="even">
<td colspan="6">9. TYPED NAME AND TITLE OF RESPONSIBLE OFFICIAL OR
AGENT<br />
     </td>
<td colspan="4">10. SIGNATURE OF RESPONSIBLE OFFICIAL</td>
</tr>
<tr class="odd">
<td colspan="6" rowspan="2">11. APPLICANT’S RETURN ADDRESS<br />
     </td>
<td colspan="4"><p>12. RESPONSIBLE OFFICIAL’S</p>
<blockquote>
<p>a. PHONE NO.</p>
<p>(     )      </p>
<p>b. FAX NO.</p>
<p>(     )      </p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="4"><p>13. FOR CBER PRODUCTS ONLY: <em>(Check One)</em></p>
<blockquote>
<p> Part I/Draft Part II/Final</p>
</blockquote></td>
</tr>
</tbody>
</table>

#### Instructions for Completing Form FDA 2253

1.  Date Submitted -- the date the 2253 Form and accompanying materials
    are sent to the FDA.

2.  Original 2567 submission for biologics, leave blank. Resubmissions,
    include previously assigned "P" review number, if known.

    3.  NDA/ANDA/AADA/PLA/BLA/PMA number. For CBER, include most recent
        reference number effecting a labeling change.

> > Single product -- Each 2253 Form and accompanying submission should
> > pertain to only one application number. The\
> > complete Form and the attached submission materials should be
> > prepared in duplicate, and should be separated for ease of handling.
>
> > Multiple products. In case where promotional materials mention
> > multiple products such as price lists, formulary lists,\
> > multiple product reminder ads, and corporate communications; three
> > specimens of the promotional piece may be filed to a\
> > single application with three 2253 Forms and labeling, and the other
> > referenced products require only an attached sheet(s)\
> > which identifies the other referenced products including:
> > application No., trade name and established name, and labeling for\
> > each referenced product.

4.  Proprietary Name -- enter the proprietary name of the drug or
    > biological product. The dosage form should also be included if\
    > it is part of the proprietary name or if it distinguished the
    > product from other dosage forms with the same trade name.

5.  Established Name -- the established (generic) name of the
    > drug/biological product. For biological product submissions,\
    > provide "Product Code No.", if known or used.

6.  Package Insert Date & No. -- the date and identification number of
    > the most current approved product labeling (including two copies).

7.  Manufacturer name and license no. -- provide this information for
    > biological product submissions.

8.  Advertising/Promotional Labeling Materials -- A detailed listing of
    > all promotional materials submitted on the 2253 Form.\
    > Each material should be individually listed per line. Consumer and
    > professional pieces should be submitted separately.

```{=html}
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8.  Material Type -- List materials submitted using the FDA Codes listed
    > below.

> > **FDA [CODE]{.underline} [TRANSLATION]{.underline} FDA
> > [CODE]{.underline} [TRANSLATION]{.underline}**
>
> CAD CONSUMER PRINT ADVERTISEMENTS PFK PROFESSIONAL PRINT FORMULARY KIT
>
> CAT CONSUMER AUDIO (TAPE/SCRIPT) PGV PROFESSIONAL GIVEAWAYS
>
> CCP CONSUMER COMPUTER DISCS/PROGRAMS/CD ROM PHO PROFESSIONAL HOUSE
> ORGAN
>
> CDM CONSUMER DIRECT MAIL PLT PROFESSIONAL DIRECT MAIL
>
> CED CONSUMER PROMOTIONAL LABELING (PRESCRIBER/PHARMACIST/WHOLESALER)
>
> COT CONSUMER -- OTHER PMN PRODUCT MONOGRAPHS
>
> CRD CONSUMER RADIO (SCRIPT/TAPE) POT PROFESSIONAL - OTHER
>
> CSK CONSUMER STARTER KITS PPO PROFESSIONAL PRINT \-- OTHER
>
> CTL CONSUMER TELEPHONE (SCRIPTS) PPR PRINT PRESS RELEASE
>
> CTV CONSUMER TELEVISION (SCRIPT/STORYBOARD/VIDEO PRC PROFESSIONAL
> REPRINT CARRIERS\
> TAPE) PRD PROFESSIONAL RADIO (SCRIPT/TAPE)
>
> CVT CONSUMER VIDEO (TAPE/STORYBOARD/SCRIPT) PRP PROFESSIONAL REPRINTS
>
> PAD PROFESSIONAL PRINT AD PSA PROFESSIONAL SALES AID (DETAILER)
>
> PAT PROFESSIONAL AUDIO TAPE/CD PSC PROFESSIONAL SAMPLE CARTON
>
> PBK PROFESSIONAL BOOK PSL PROFESSIONAL SLIDES
>
> PCP PROFESSIONAL COMPUTER DISCS/PROGRAMS/CD ROMS PTL PROFESSIONAL
> TELEPHONE (SCRIPT)
>
> PCT PROFESSIONAL PRICE CATALOGS PTV PROFESSIONAL TELEVISION
> (SCRIPT/STORYBOARD/VIDEO TAPE)
>
> PDS PROFESSIONAL DRUG SAMPLE PVT PROFESSIONAL VIDEO TAPE
>
> PEP PROFESSIONAL EXHIBIT PANEL VNR VIDEO NEWS RELEASES
>
> PFC PROFESSIONAL FILE CARD WWW INTERNET PROMOTION
>
> PFE PROFESSIONAL FORMULARY ECONOMIC OM OTHER MISCELLANEOUS (EXPLAIN)

8.  Dissemination/Publication Date -- the date of the initial
    dissemination of the promotional labeling or the date of initial\
    publication for a journal advertisement.

    8.  Applicant's Material ID Code -- the applicant's identification
        code or other designation of the specific promotional material.

        8.  Previous review No. and date if biological product
            submission, if applicable.

            9.  Typed Name and Title of Responsible Official -- the
                individual responsible for responding to any inquires
                regarding the 2253\
                submission.

            10. Signature of Responsible Official

            11. Applicant's Return Address

            12. a & b. Telephone and FAX Numbers -- the telephone and
                facsimile numbers of the responsible official.

            13. Biological products: check #1 if submitting draft; check
                #2 for final copy

> **NOTE: Forward Form and attachments for drugs to: Food and Drug
> Administration, Center for Drug Evaluation and\
> Research, Division of Drug Marketing, Advertising, and Communication,
> 5901-B Ammendale Road, Beltsville,\
> MD 20705**
>
> **Forward Form and attachments for biologics to: Department of Health
> and Human Services,\
> Food and Drug Administration, CBER (HFM-202), 1401 Rockville Pike,
> Rockville, MD 20852-1448.**
>
> **Public reporting burden for this collection of information** is
> estimated to average 2 hours per response, including the time for\
> reviewing instructions, searching existing data sources, gathering and
> maintaining the data needed, and completing and reviewing the\
> collection of information. Send comments regarding this burden
> estimate or any other aspect of this collection of information,
> including suggestions for reducing this burden to:
>
> Food and Drug Administration *An agency may not conduct or sponsor,
> and a person is not required to respond to, a*\
> Center for Drug Evaluation and Research *collection of information
> unless it displays a currently valid OMB control number.*
>
> Division of Drug Marketing, Advertising, and Communications\
> 5901-B Ammendale Road
>
> Beltsville, MD 20705

Please **DO NOT RETURN** this form to this address.