FDA Phospholipidosis Guidance Being Developed; Toxicity Is Concern
FDA is planning to develop a guidance on phospholipidosis issues in drug products
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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...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials