Business Wire - GSK Receives Approvable Letter for Topical Antibiotic, Altabax™ , 1%
Thursday, October 30th, 2008 PHILADELPHIA — 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 asses…
