After meeting with regulatory agencies, Gensia PharmaceuticalsInc. announced Monday that it plans to submit a new drugapplication (NDA) for Arasine to the FDA by the end of theyear.
The San Diego company (NASDAQ:GNSA) also plans to file inJanuary 1993 a marketing authorization application (MAA) inEurope.
Phase III trials of Arasine for its first indication in patientsundergoing coronary artery bypass surgery were completed inJune, and according to Gensia spokeswoman Elizabeth Gard, thecompany is now designing a follow-up multicenter trial asadditional support of the drug for the same indication that isdue to begin late this year or early in 1993.
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