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GSK News GSK Receives Approvable Letter for Topical Antibiotic, Altabax(TM) (retapamulin ointment), 1%

PHILADELPHIA--(BUSINESS WIRE)--GlaxoSmithKline (GSK) announced today that the U.S. Food and Drug Administration has issued an approvable letter for its topical antibacterial, Altabax (retapamulin ointment), 1%, for the treatment of secondarily-infected traumatic lesions (SITL). SITL is a type of skin and skin structure infection most commonly caused by Staphylococcus aureus and Streptococcus pyogenes.

In the letter to GSK, the FDA requested additional information to complete its assessment of Altabax as a treatment for SITL; no safety concerns were noted. GSK intends to respond in full to the FDA's requests and work with the agency to pursue approval of Altabax for the treatment of SITL.

The FDA also notified GSK that it did not approve a second indication, for the treatment of secondarily-infected dermatoses (SID), in the same New Drug Application (NDA). The FDA will require additional clinical studies to consider approving Altabax as a treatment for SID. GSK is currently in discussions with the FDA regarding these studies.

A separate Altabax NDA for the treatment of impetigo is also currently being reviewed by the FDA. Impetigo is a superficial skin infection most commonly seen in children. The NDA for the impetigo indication is based primarily on the results of a double-blind, placebo-controlled clinical study demonstrating that the efficacy of Altabax was superior to placebo in adults and children. GSK expects to receive the FDA's decision for this indication in 2Q 2007.

Retapamulin belongs to a new class of antibiotics called pleuromutilins and demonstrates a unique mode of action that is different from currently available antibiotics. Due to this unique mode of action, retapamulin exhibits a low potential for the development of resistance in vitro.

GlaxoSmithKline has an established heritage in the development of novel anti-infectives to meet clinical needs. These products include the topical antibacterial agent Bactroban® (mupirocin) as well as the oral agent Augmentin® (amoxicillin/clavulanate potassium). GlaxoSmithKline, one of the world’s leading research-based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer. Additional information about GlaxoSmithKline can be found online at www.gsk.com.