US approval of Fosrenol delayed
Shire Pharmaceuticals Group, of Basingstoke in the UK, has received a letter from the US FDA indicating a 90-day extension to the review period for Fosrenol (lanthanum carbonate) to complete evaluation of new data relating to the formulation and dosage strengths, submitted by Shire at the request of FDA.
Shire Pharmaceuticals Group, of Basingstoke in the UK, has received a letter from the US FDA indicating a 90-day extension to the review period for Fosrenol (lanthanum carbonate) to complete evaluation of new data relating to the formulation and dosage strengths, submitted by Shire at the request of FDA.
But the Company expects no change to its targeted 2004 launch timing and is proceeding with all prelaunch activities. It stresses that no concerns are raised in the letter about the drug's clinical safety or efficacy.
The original action date was to be 26 July but the extension of the review moves the final action date and anticipated approval to 26 October. Labelling discussions for the product will take place in parallel during this 90-day period.
The regulatory authorities in Sweden approved Fosrenol in March, and further European approvals are expected by the end of 2004. Fosrenol is a novel phosphate binder that reduces high blood levels of phosphorus in End-Stage Renal Disease (ESRD) patients on dialysis.