Biotech Values

[DewDiligence]

Cases Where FDA Rejected a Drug Endorsed by Advisory Panel

[Edited Lasofoxifene entry.]

 
                        Panel Vote   Date of FDA    Ultimate     iHub  
 Company    Drug       For Approval  Non-approval   Resolution   Reference 
 AMGN     Prolia           15-0‡       10/09       apprvd 06/10  #msg-50796707 
 AZN      Brilinta          7-1         7/10       apprvd 07/11  #msg-65396139 
 BMY      Belatacept       13-5         5/10       apprvd 06/11  #msg-64295530 
 DNDN     Provenge         13-4         5/07       apprvd 05/10  #msg-19483904 
 ITMN     Pirfenidone       9-3         5/10       ?             #msg-49777513 
 MRK      Bridion          14-0         8/08       ?             #msg-31141155 
 MRK      Suvorexant       12-4*        5/13       ?             #msg-89531970 
 OREX     Contrave         13-7         2/11       ?             #msg-59389692 
 PFE      Lasofoxifene      9-3         1/09       abandoned     #msg-34890112 
 Roche    Actemra          10-1        12/08       apprvd 01/10  #msg-33965815 
 TTNP     Probuphine       10-4         5/13       ?             #msg-87437846 

‡12-3 vote for prevention of postmenopausal osteoporosis.

*8-7 vote against safety of 30mg/40mg doses.