FDA issues approvable letter for GSK's Altabax

UK-based drug major GlaxoSmithKline says that the US Food and Drug Administration has issued an approvable letter for Altabax (retapamulin ointment) 1%, its developmental antibacterial for the treatment of secondarily-infected traumatic lesions (SITL). The company told the Marketletter that, while no safety issues were raised by the FDA, the letter did request further information that would enable the agency to evaluate the effectiveness of the drug, prior to its approval decision.

In addition, GSK said that the FDA had not approved the drug as a treatment for dermatoses (skin defects or lesions), and added that the agency would require further clinical studies before it would begin considering it for this indication.

GSK said that it intends to fully respond to the approvable letter, going on to say that it is in discussions with the FDA regarding the second indication. The UK drug major added that the drug is also under FDA consideration as a therapy for the skin condition impetigo.