Sepracor Soltara “not approvable”
Executive Summary
Sepracor's NDA for allergic rhinitisproduct Soltara (tecastemizole) deemed "not approvable" March 6. FDA wants additional assurance that there is no potential for QTc prolongation with the product. FDA also raised issues related to phospholipidosis and cardiomyopathy observed in animal safety studies. The Soltara NDA was submitted March 9, 2001. Soltara is a metabolite of Janssen's Hismanal (astemizole), which was removed from the market in 1999 due to cardiac side effects...