Drugs in the Pipeline Analysis

Generic Drug
Name (Brand)
Drug Company
Route Indication(s) Regulatory
Priority review * Status
Therapeutic Considerations
Affected
Population
Estimated
Peak Sales
Estimated
Cost/day
The regulatory road for gepirone ER has
been a long one, stemming back to
2001, under the direction of several
different sponsors. FKP re-acquired
rights to gepirone ER from Akzo Nobel's
Organon in 2005. That action was taken
after the drug was determined twice by
FDA to be "not approvable." The drug
was originally submitted in 2001 and
deemed not approvable in April 2002
due to efficacy concerns. Organon
withdrew an NDA for the antidepressant
in 2004 after receiving a second not
approvable letter from FDA.
Abbreviations: NA = not available.
*Priority Review: an FDA designated status where the drug appears to represent an advance over available therapy. The FDA review time for these
drugs is usually shorter than other drugs (6 months compared to 10 months). 1P: priority review of a new molecular entity, 2P: priority review of a
chemical derived from a FDA approved drug, 3P: priority review of a new formulation of a FDA approved drug, 4P: priority review of a new combination
of FDA approved drugs.
Updated 8/2007
Copyright © 2007 Medco Health Solutions, Inc.
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