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FDA requires more data on Schering's Saphris
16 Jan 2009
Regulatory Affairs
The US Food and Drug Administration (FDA) has revealed it wants more data on Schering-Plough's schizophrenia drug.
A complete response letter was received by the company from the FDA about the drug asenapine, to be marketed as Saphris, which can also treat manic or mixed episodes or bipolar I disorder in adults.
Schering-Plough has revealed the authority does not require further clinical trials into the drug and says the requested information should be delivered in the first quarter of this year.
Thomas Koestler, president of the Schering-Plough Research Institute, says the firm is "pleased with the progress" of the current filing for the drug.
He adds: "New treatments are needed in this therapeutic area and we believe that Saphris has the potential to be an important option."
In December last year Schering-Plough received approval from the FDA to market the Pegintron and Rebetol combined therapy to treat chronic hepatitis C.
