The dates may have changed since the time it was updated
Keep checking http://www.freefdawatchlist.com for latest information.
* VITA CORTOSS Bone Augmentation Material in vertebral augmentation
* PREMF Pending FDA approval status (can be a big gainer ??)
* UIU waiting for FDA approval of Astrazeal silver.
* BLTI December
* NURO waiting for two FDA clearance.
* CXM review date September 30th 2009 (delay)
* GTF FDA clearance December 2009
* ELN PDUFA date October 22nd 2009 Fampridine
* NPHC expected FDA annoucement in October 2009.
* GTXI PDUFA review date October 30th 2009
* NRIFF PDUFA review date November 4th 2009
* NGSX PDUFA review date November 16th 2009 Quenteza
* CRXX delayed
* EPCT filed NDA in August 2009
* DYAX PDUFA review date December 1st 2009
* ATEC 510(K)clearance Jan 2010
* MNKD PDUFA date January 1st 2010
Ticker Date EST. DATE Event
NEPH ANYTIME 510(k)
NEPH ANYTIME 510(k)
NSPH ANYTIME 510(k)
VSGN ANYTIME ANDA
SVNT 8/1/2009 BLA
NGSX 8/16/2009 NDA
NSPH 8/31/2009 510(k)
ENDP 9/2/2009 NDA
SPPI 9/7/2009 sBLA
SLXP 9/11/2009 NDA
ISTA 9/12/2009 NDA
AUXL 9/16/2009 ADVISORY REVIEW
BSTC 9/16/2009 ADVISORY REVIEW
THRX 9/16/2009 NDA
EURX 9/23/2009 NDA
CRXX 9/23/2009 ADVISORY REVIEW
CXM 9/30/2009 510(k)
SPPI 10/8/2009 sNDA
BIEL 10/15/2009 510(k)
ACOR 10/22/2009 NDA
GTXI 10/30/2009 NDA
BVX 10/31/2009 510(k)
BVX 10/31/2009 510(k)
TSPT 10/31/2009 NDA
XNPT 11/9/2009 NDA
CADX 11/13/2009 NDA
TRIB 11/20/2009 CLIA
BVX 11/22/2009 510(k)
CRXX 11/22/2009 NDA
ICAD 11/26/2009 510(k)
THRX 11/26/2009 NDA
DYAX 12/1/2009 BLA
MELA 12/4/2009 PMA
SOMX 12/4/2009 NDA
SNTS 12/4/2009 NDA
GTF 12/7/2009 510(k)
SNTS 12/9/2009 NDA
MELA 12/9/2009 510(k)
BVX 12/31/2009 510(k)
STAA 12/31/2009 sPMA
NURO END 09
NURO END 09
OSTE END 09 510(k)
MNKD 1/16/2010 NDA
OSIP 1/18/2010 sNDA
WCRX 1/26/2009 NDA
SEPR 1/30/2010 NDA
PRX 2/7/2010 NDA
AMLN 3/5/2010 NDA
SUPG 3/8/2010 sNDA
APPA 3/18/2010 NDA
HGSI 3/21/2010 BLA
THOR 3/31/2010 sPMA
APPY 3/31/2010 510(k)
PRX 4/15/2010 NDA
SLXP 4/24/2009 NDA
POZN 4/30/2010 NDA
CEPH 4/30/2010 sNDA
CRTX 5/15/2010 RF
PLX 6/4/2010 sNDA
IGXT TBD NDA
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