FDA Approval Decisions Report

November, 2006

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Date: Nov 01, 2006
Format: PDF
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Abstract

The Revere FDA Approval Decision Report provides one of the most comprehensive and accurate event calendars for PDUFA dates (Prescription Drug User Fee Act) - expected FDA approval dates for NDA/BLA filed drugs. In particular, this report identifies Biotech/Pharmaceutical companies with expected FDA approvals in the next 3 months and reviews all FDA approval decisions in the current month. Furthermore, the report also analyzes each drug candidate's likelihood of approval and competitive landscape using 3 criteria derived from Revere's patented classification system: (1) Utilization of a mechanism of action previously approved by the FDA, (2) Facing two or fewer alternative drugs with the same mechanism of action for the same indication, and (3) Would be the first or second FDA approved drug for the company. Original, unbiased, insightful and actionable, the Revere FDA Approval Decision Report is an indispensable tool for successful Biotech/Pharmaceutical investing.

Content

This Revere Report features companies with expected FDA approval decision dates in the next three months. To provide further insights into each drug candidate's likelihood of approval andcompetitive landscape, the FDA Approval Decisions Report includes key data based on Revere's patented classification system and proprietary pipeline database.

Some of the candidates included in this report are:

Drug NamesPMOA
Galvus (Vildagliptin)Dipeptidyl Peptidase Inhibitors
Entereg (Alvimopan)Opioid Receptor Antagonists
Mesavance (Mesalamine)COX Inhibitors, Lipoxygenase Inhibitors
Cimzia (Certolizumab Pegol)TNF-Alpha Antagonists
Nuvigil (Armodafinil)Alpha Adrenergic Receptor Agonists

Companies Mentioned in the Report