New Drug Applications Archive
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December 2007
December 3
December 6
December 7
FDA Reviewing Potential Anti-Arrhythmic Claims for Ranexa
Medarex to Receive Milestone Payment for Submission of Regulatory
Applications Requesting Approval of Ustekinumab (CNTO 1275) for
Treatment of Psoriasis
FDA Advisory Committee Votes Unanimously to Recommend Approval of
Tetrabenazine for Chorea Associated With Huntington Disease
Neurochem Announces Eprodisate (Kiacta) Receives Acknowledgement of
Complete Response and is Granted Class 2 Review
DOR BioPharma Announces Results of orBec End of Review Conference
with the FDA
December 12
December 13
December 17
December 19
December 20
Introgen Plans to Expand Biomarker Database in Phase 3 Trials and
File BLA and MAA for Advexin in Advanced Head and Neck Cancer in
First Half of 2008
GlaxoSmithKline Files for FDA Approval of Promacta (eltrombopag) to
be the First Oral Platelet Growth Factor for Rare Blood Disorder
Eurand Completes New Drug Application for Zentase
December 21
Jerini Receives NDA Filing Acceptance and Priority Review from the
FDA for Icatibant in the Treatment of HAE
Ligand Earns $1 Million Milestone Payment as GlaxoSmithKline
Submits New Drug Application for Promacta (eltrombopag)
New Drug Application for Tolvaptan, Otsuka's Investigational Novel
Oral Treatment for Worsening Heart Failure and Hyponatremia,
Accepted by the U.S. Food and Drug Administration
Pfizer Receives Approvable Letter from FDA for Dalbavancin
