This posting is intended to provide guidance regarding the
implementation of the final rule **Labeling Requirements for Systemic
Antibacterial Drug Products Intended for Human Use** (68 FR 6062,
February 6, 2003).

A copy of the rule can be obtained at:
<http://www.fda.gov/OHRMS/DOCKETS/98fr/00n-1463-nfr00001.pdf>. Under
this rule, applicants are required to implement revised labeling for
systemic antibacterial drug products by February 6, 2004.

To respond to this rule, submit a supplement - identified as a "Special
Supplement: Changes Being Effected" (CBE) that includes final printed
labeling (FPL) -- in accordance with the November 2000 Guidance for
Industry "Changes to an Approved NDA or ANDA". Each supplement should
contain only changes related to this rule. The following information
should be included in the submission:

A. **Cover Letter**

Indicate that the submission is a CBE for the sole purpose of addressing
the systemic antibacterial final rule.

B. **Revised Labeling**

The label must include the following:

1.  At the beginning of the label, under the "**Product Name**", the
    labeling must state:

> "To reduce the development of drug-resistant bacteria and maintain the
> effectiveness of [\[Insert name of antibacterial drug
> product\]]{.mark} and other antibacterial drugs[, \[Insert name of
> antibacterial drug product\]]{.mark} should be used only to treat or
> prevent infections that are proven or strongly suspected to be caused
> by bacteria."

2.  In the "**INDICATIONS AND USAGE"** section, the labeling must state:

> "To reduce the development of drug-resistant bacteria and maintain the
> effectiveness of [\[Insert name of antibacterial drug
> product\]]{.mark} and other antibacterial drugs [\[Insert name of
> antibacterial drug product\]]{.mark} should be used only to treat or
> prevent infections that are proven or strongly suspected to be caused
> by susceptible bacteria. When culture and susceptibility information
> are available, they should be considered in selecting or modifying
> antibacterial therapy. In the absence of such data, local epidemiology
> and susceptibility patterns may contribute to the empiric selection of
> therapy."

3.  In the **"PRECAUTIONS"** section, under the "General" subsection,
    the labeling must state:

> "Prescribing [\[Insert name of antibacterial drug product\]]{.mark} in
> the absence of a proven or strongly suspected bacterial infection or a
> prophylactic indication is unlikely to provide benefit to the patient
> and increases the risk of the development of drug- resistant
> bacteria."

4.  In the **"PRECAUTIONS**" section, under the "Information for
    Patients" subsection, the labeling must state:

> "Patients should be counseled that antibacterial drugs including
> [\[Insert name of antibacterial drug product\]]{.mark} should only be
> used to treat bacterial infections. They do not treat viral infections
> (e.g., the common cold). When [\[Insert name of antibacterial drug
> product\]]{.mark} is prescribed to treat a bacterial infection,
> patients should be told that although it is common to feel better
> early in the course of therapy, the medication should be taken exactly
> as directed. Skipping doses or not completing the full course of
> therapy may (1) decrease the effectiveness of the immediate treatment
> and (2) increase the likelihood that bacteria will develop resistance
> and will not be treatable by [\[Insert name of antibacterial drug
> product\]]{.mark} or other antibacterial drugs in the future."

Submit an electronic version of the FPL according to the guidance for
industry titled *Providing Regulatory Submissions in Electronic Format -
NDA*. Alternatively, you may submit 20 paper copies of the FPL, fifteen
of which are individually mounted on heavyweight paper or similar
material. Incorporate all previous revisions as reflected in the most
recently approved package insert. To facilitate review of your
submission, provide a highlighted or marked-up copy that shows the
changes that are being made.

If you have any questions, contact the regulatory project manager
associated with your application. Additional questions can be sent to
<antimicrobial@cder.fda.gov>.