R-PR's ebastine "not approvable" in USA
The US Food and Drug Administration has told Rhone-Poulenc Rorer thatits ebastine is "not approvable" for the treatment of allergic rhinitis on the basis of the information supplied to the agency in the New Drug Application, filed in March 1998.
A spokesperson for the company said it was not divulging details of the reasons behind the FDA's decision, only that it concerned the risk/benefit ratio of the product. R-PR added that it had notified the FDA of its intent to amend the NDA and would be submitting additional efficacy and side effect data to the agency, probably within the next 60 days, from its US trials conducted after the filing of the NDA.
Ebastine, originally developed by Spain's Almirall Prodesfarma, is available as Kestine in the Netherlands, Spain, Japan, South Korea and Pakistan.
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