Dear Healthcare Provider:

The U.S. Food and Drug Administration's (FDA) Division of Drug Marketing, Advertising and Communications (DDMAC) has notified GlaxoSmithKline (GSK) that a professional promotional piece contained misleading information in that it broadened the indication of ALTABAX made unsubstantiated superiority claims to mupirocin, and omitted and minimized important risk information associated with the use of ALTABAX. Please be assured that this was never the intent of GSK, as GSK is committed to providing you with appropriate information regarding its medicines.

This letter is sent to you to address the concerns cited in their Warning Letter.

According to the FDA-approved prescribing information, ALTABAX is indicated for use in adults and pediatric patients aged 9 months and older for the topical treatment of impetigo (up to 100 cm² in total area in adults or 2% total body surface area in pediatric patients aged 9 months or older) due to Staphylococcus aureus (methicillin-susceptible isolates only) or Stveptococcus pyogenes. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ALTABAX and other antibacterial drugs, ALTABAX should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

We wish to call your attention to the following corrective important information for ALTABAX.

• ALTABAX is not approved to treat impetigo caused by methicillin-resistant isolates of Staphylococcus aureus (MRSA).
• ALTABAX is also not approved to treat impetigo caused by Staphylococcus aureus strains that are resistant to mupirocin.
• ALTABAX is not approved to treat any other uncomplicated SSSIs other than impetigo.
• There are no clinical trials to indicate that ALTABX is superior to mupirocin or any other therapeutic agent for the treatment of impetigo.
• In vitro activity, which was used in the professional slim jim, does not necessarily correlate with clinical efficacy. The FDA is unaware of any data or substantial evidence demonstrating the superior efficacy of Altabax to mupirocin with regards to the development of resistance, potency, post-antibiotic effect, or mechanism of action.
• In the event of sensitization or severe local irritation from ALTABAX, usage should be discontinued, the ointment wiped off, and appropriate alternative therapy for infection instituted.
• ALTABAX is not intended for ingestion or for oral, intranasal, ophthalmic, or intravaginal use. ALTABAX has not been evaluated for use on mucosal surfaces.
• The use of antibiotics may promote the selection of nonsusceptible organisms. Should superinfection occur during therapy, appropriate measures should be taken.
• Prescribing ALTABAX in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria.
• The most common drug-related adverse reaction associated with the use of ALTABAX is application site irritation (1 -4% of patients).

Please take the time to review the complete prescribing information for ALTABAX though the link provided at the top or bottom of the page.

If you have any questions or require additional information, please call the GSK Response Center
888-825-5249.

Sincerely,

Alison Webster MD FRCPath
Interim Therapy Area Clinical Lead
Infectious Diseases Medicines Development Centre