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GSK drug moves towards regulatory approval
29 Dec 2006
Clinical Research
UK-based pharmaceutical firm GlaxoSmithKline (GSK) has received an approvable letter for a new drug from the US Food and Drug Administration (FDA), the company reports.
Altabax (retapamulin ointment), a topical antibacterial, has moved towards full regulatory approval in one indication, but not another that the company applied for.
The application for Altabax to be used in the treatment of secondarily-infected traumatic lesions (SITL) will continue, but further information has been requested before it can be considered any further for the treatment of secondarily-infected dermatoses (SID).
"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 company said in a press statement.
"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," the firm added.
GSK claims that Altabax works in a completely different way to existing antibiotics, and as such has a far lower susceptibility to a patient developing an immunity to it.
The company employs over 15,000 research staff at a range of locations worldwide, including at its UK base in Middlesex.
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