FDA's NDA And BLA Approvals: Caspofungin
Executive Summary
Original new drugs and biologics recently approved by US FDA.
Below are FDA's original approvals of NDAs and BLAs issued in the past week. Please see key below chart for a guide to frequently used abbreviations.
Sponsor |
Product |
Indication |
Code |
Approval Date |
New Drugs |
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Fresenius Kabi |
Caspofungin acetate |
Injectable echinocandin antifungal for empirical therapy for presumed fungal infections in febrile, neutropenic patients; treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections; treatment of esophageal candidiasis; treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies |
S, 5 |
12/30/2016 |
Key To Abbreviations |
Review Classification |
P: Priority review; S: Standard review; O: Orphan Drug |
NDA Chemical Types |
1: New molecular entity (NME); 2: New active ingredient; 3: New dosage form; 4: New Combination 5: New formulation or new manufacturer; 6: New indication; 7: Drug already marketed without an approved NDA; 8: OTC (over-the-counter) switch; 9: New indication submitted as distinct NDA – consolidated with original NDA; 10: New indication submitted as distinct NDA - not consolidated with original NDA |