FDA Approval Decisions Report
November, 2006
| Date: | Nov 01, 2006 |
|---|---|
| Format: | |
| View Report » |
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 Names | PMOA |
|---|---|
| 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
- Novartis AG (ADR) (NVS) - Overview - Reports
- Merck & Co., Inc. (MRK) - Overview - Reports
- Millennium Pharmaceuticals, Inc. (?215215) - Overview - Reports
- Eli Lilly & Co. (LLY) - Overview - Reports
- Indevus Pharmaceuticals (IDEV) - Overview - Reports
- Genta Incorporated (GNTA) - Overview - Reports
- Oscient Pharmaceuticals Corporation (OSCI) - Overview - Reports
- Forest Laboratories, Inc. (FRX) - Overview - Reports
- Novadel Pharma Inc (NVD) - Overview - Reports
- Eisai Co., Ltd (ADR) (ESALY) - Overview - Reports
- Cephalon, Inc. (CEPH) - Overview - Reports
- AVANIR Pharmaceuticals (AVNR) - Overview - Reports
- Amylin Pharmaceuticals, Inc. (AMLN) - Overview - Reports
- Wyeth (WYE) - Overview - Reports
- Pfizer Inc. (PFE) - Overview - Reports
- Par Pharmaceutical Companies, Inc. (PRX) - Overview - Reports
- Roche Holding Ltd. (ADR) (RHHBY) - Overview - Reports
- Sepracor Inc. (SEPR) - Overview - Reports
- Schering-Plough Corporation (SGP) - Overview - Reports
- Shire Plc. (ADR) (SHPGY) - Overview - Reports
- AstraZeneca plc (ADR) (AZN) - Overview - Reports
- Idenix Pharmaceuticals, Inc. (IDIX) - Overview - Reports
- Genentech, Inc. (DNA) - Overview - Reports
- BioSante Pharmaceuticals, Inc. (BPAX) - Overview - Reports
- Adolor Corporation (ADLR) - Overview - Reports
- GlaxoSmithKline plc (ADR) (GSK) - Overview - Reports
- Altana AG (ADR) (AAAGY) - Overview - Reports
- Replidyne, Inc. (RDYN) - Overview - Reports
- Schwarz Pharma, Inc. (SRZ:F) - Overview - Reports