FDA Approval Decisions Report
July, 2009
| Date: | Jul 01, 2009 |
|---|---|
| Format: | ZIP |
| Price: | $125.00 |
Abstract
The Revere FDA Approval Decision Report 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 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:
- Utilization of a mechanism of action previously approved by the FDA.
- Facing two or fewer alternative drugs with the same mechanism of action for the same indication.
- Would be the first or second FDA approved drug for the company.
Included Bonus New BioMedicine Biotech Research Reports
- Theravance, Inc. (THRX) - Special Event Report - FDA approval of Telavancin
- Labopharm Inc. (DDSS) - Special Event Report - FDA approval of Trazodone Contramid Once-Daily
Each New BioMedicine Biotech Research Report provides in-depth analysis relating to an upcoming event for a select pipeline drug. The report forecasts the expected event outcome (positive/negative), and discusses the relevant company, the drug candidate, market opportunity, clinical trials results, and competitive landscape.
The Biotech Research Report is unique in its focus on events likely to drive large price movements within narrow timeframes, and because it forecasts event outcomes based on rigorous analysis of clinical results and regulatory factors.
Companies Mentioned in the Report
- Abbott Laboratories (ABT) - Overview - Reports
- AMAG Pharmaceuticals, Inc. (AMAG) - Overview - Reports
- Savient Pharmaceuticals, Inc. (SVNT) - Overview - Reports
- Bristol Myers Squibb Co. (BMY) - Overview - Reports
- Eli Lilly & Co. (LLY) - Overview - Reports
- GlaxoSmithKline plc (ADR) (GSK) - Overview - Reports
- Acura Pharmaceuticals, Inc. (ACUR) - Overview - Reports
- Biogen Idec Inc. (BIIB) - Overview - Reports
- Johnson & Johnson (JNJ) - Overview - Reports
- Medarex inc. (?214788) - Overview - Reports
- Merck & Co., Inc. (MRK) - Overview - Reports
- Spectrum Pharmaceuticals, Inc. (SPPI) - Overview - Reports
- Novartis AG (ADR) (NVS) - Overview - Reports
- Pfizer Inc. (PFE) - Overview - Reports
- Pharmaceutical Product Development Inc (?218819) - Overview - Reports
- Teva Pharmaceutical Industries Ltd (ADR) (TEVA) - Overview - Reports
- ViroPharma Incorporated (VPHM) - Overview - Reports
- Watson Pharmaceuticals, Inc. (WPI) - Overview - Reports
- AstraZeneca plc (ADR) (AZN) - Overview - Reports
- King Pharmaceuticals, Inc. (?212886) - Overview - Reports
- United Therapeutics Corporation (UTHR) - Overview - Reports
- Allos Therapeutics, Inc. (ALTH) - Overview - Reports
- Roche Holding AG (RHHBY) - Overview - Reports
- Endo Pharmaceuticals (ENDP) - Overview - Reports
- Salix Pharmaceuticals, Ltd. (SLXP) - Overview - Reports
- ISTA Pharmaceuticals, Inc. (ISTA) - Overview - Reports
- Nuvo Research Inc. (NRIFF) - Overview - Reports
- Eurand N.V. (?966820) - Overview - Reports
- Sanofi (SNY) - Overview - Reports
- BioDelivery Sciences International, Inc. (BDSI) - Overview - Reports
- Theravance, Inc. (THRX) - Overview - Reports
- Takeda Yakuhin Kogyo KK (TKPYY) - Overview - Reports
- Advanced Life Sciences Holdings Inc (ADLS.1) - Overview - Reports
- NeurogesX, Inc (NGSX) - Overview - Reports
- Covidien plc (COV) - Overview - Reports
More Information:
Learn more about FDA Approval Decisions Report.