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25 [micro]g/ml] plus amphotec [MIC-90 of 1 [micro]g/ml]), maintenance and consolidation therapy (voriconazole).
Amphotec has only one labeled indication: treatment of invasive aspergillosis.
We are pleased that the FDA has agreed to include this additional information in the AMPHOTEC label," said Dr.
Combined revenues from sales of DOXIL and AMPHOTEC were below analysts' expectations.
The analysis included 82 patients with proven or probable aspergillosis who were treated with AMPHOTEC in one of five open-label clinical trials and 261 patients with aspergillosis treated with amphotericin B at six cancer or transplant centers from January 1990 to June 1994.
The results of this study confirm our belief that AMPHOTEC provides the best combination of clinical benefit and value.
We are pleased that to our knowledge, our drug, AMPHOTEC, will be the fist lipid-based antifungal agent to be evaluated by an advisory committee for this indication.
Outside the United States, AMPHOTEC is cleared for marketing for the treatment of severe systemic and/or deep mycoses in patients for whom conventional amphotericin B therapy cannot be used in effective doses due to toxicity or impaired renal function or in patients who have failed conventional systemic antifungal therapy.
AMPHOTEC, also known as amphotericin B colloidal dispersion or ABCD, is a proprietary drug designed to treat progressive and potentially fatal systemic fungal infections.
AMPHOTEC will be marketed in Israel by Gamida-MedEquip Limited under the trade name AMPHOCIL(TM).
9, 1996--Data from a double-blind, randomized clinical trial comparing AMPHOTEC with amphotericin B in the empiric treatment of febrile neutropenic patients, presented today at the "38th American Society of Hematology Annual Meeting," showed that AMPHOTEC was equally effective and substantially less toxic to the kidney, as compared to conventional amphotericin B, the standard therapy, in treating this patient population.
We began receiving orders from the field as soon as we announced FDA market clearance of AMPHOTEC and we are currently filling those orders," said chairman and chief executive officer, Dr.