From FDA Calendar 03/31/2014 Durata The
Post# of 63828
Posted On: 03/11/2014 7:48:45 AM
From FDA Calendar
| 03/31/2014 | Durata Therapeutics | DRTX | Tedizolid phosphate tablets and Tedizolid phosphate injection (NDAs) | FDA panel to review the 2 product candidates for the proposed indication of treatment of acute bacterial skin and skin structure infections. | | ||||||
| 03/31/2014 | Durata Therapeutics | DRTX | Dalbavancin hydrochloride (NDA) | FDA panel to review Dalbavancin hydrochloride for the proposed indication of treatment of acute bacterial skin and skin structure infections | | ||||||
| 03/27/2014 | EXACT Sciences Corp. | EXAS | Cologuard (PMA) | FDA panel to review Cologuard stool-DNA-based, non-invasive colorectal cancer screening test | | ||||||
| 03/26/2014 | Epigenomics AG Berli | EPGNF.PK | Epi proColon (PMA) | FDA panel to review Epi proColon test for the detection of methylated Septin 9 DNA in plasma derived from patient whole blood specimens | | ||||||
| 03/19/2014 | Paladin Labs Inc. | PLDLF.OB, PLB.TO | Impavido (NDA) | FDA decision on Impavido for the treatment of leishmaniasis | | ||||||
| 03/15/2014 | Pfizer Inc. | PFE | Eliquis (sNDA) | FDA decision on Eliquis in addnl. indication of treating prophylaxis of deep vein thrombosis following hip or knee replacement surgery |
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