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FDA Data on PDUFA Drug Approvals, Safety Withdrawals
and New Boxed Warnings

FDA is making available to the public our data related to PDUFA New Molecular Entity (NME) drug approvals, safety-based withdrawals and new boxed warnings.  These data reflect all NMEs received from January 1, 1993 – December 31, 2004, and approved through 2005, as well as safety-based drug withdrawals from the market and new boxed warnings for these NMEs that have occurred through December 2007.

Approved New Molecular Entities (NMEs) Received January 1, 1993 – December 31, 2004 and Approved through 2005

FDA Safety Based Withdrawals and New Boxed Warnings through 2007
FDA Data

 

# of NMEs

Safety Based Withdrawal

New Boxed Warning

 

Yes

No

%

P-Value

Yes

No

%

P-Value

Total

314

11

 

 

0.19

29

 

 

0.395

Deadline Approval*

88

5

83

5.7%

 

10

78

11.4%

 

All Other Approvals

226

6

220

2.7%

 

19

207

8.4%

 

*Deadline Approval defined as a first cycle approval in month 5 or 6 for PDUFA priority review NMEs, month 11 or 12 for PDUFA I standard review NMEs or month 9 or 10 PDUFA II-III standard review NMEs. These timeframes are not necessarily the same as FDAs PDUFA performance goals for NDA review on individual applications.

P-values were calculated comparing the rates of safety-based withdrawals or new boxed warnings for deadline approvals vs. approvals at any other time in the review process.

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Listing of New Molecular Entities (NMEs) Received January 1, 1993 – December 31, 2004 which have had a Safety-Based Market Withdrawal

FDA Safety Based Withdrawals through 2007

Trade Name Active Ingredient FDA Received Date Approval Date Total Time to Approval (months) # of Review Cycles Review Priority DEADLINE* NO DEADLINE Safety-Based Withdrawal Date FDA Link
Bextra Valdecoxib 16-Jan-01 16-Nov-01 10 1 S X   06-Apr-05 information
Vioxx Rofecoxib 23-Nov-98 20-May-99 5.9 1 P X   30-Sep-04 information
Baycol Cerivastatin Sodium 26-Jun-96 26-Jun-97 12 1 S X   08-Aug-01 information
Rezulin Troglitazone 01-Aug-96 29-Jan-97 6 1 P X   22-Mar-00 information
Raxar Grepafloxacin Hydrochloride 08-Nov-96 06-Nov-97 11.9 1 S X   27-Oct-99 information
Orlaam Levomethadyl Acetate Hydrochloride 21-Jun-93 09-Jul-93 0.6 1 P   X 23-Aug-03 information
Raplon Rapacuronium Bromide 25-Jun-98 18-Aug-99 13.8 2 S   X 27-Mar-01 information
Lotronex Alosetron Hydrochloride 30-Jun-99 09-Feb-00 7.4 1 P   X 28-Nov-00 information
Duract Bromfenac Sodium 30-Dec-94 15-Jul-97 27.7 3 S   X 22-Jun-98 information
Posicor Mibefradil Dihydrochloride 11-Mar-96 20-Jun-97 15.3 2 S   X 08-Jun-98 information
Zelnorm Tegaserod Maleate 11-Feb-00 24-Jul-02 29.4 3 P   X 30-Mar-07 information

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Listing of New Molecular Entities (NMEs) Received January 1, 1993 – December 31, 2004 which have had a New Boxed Warning

New Boxed Warnings through 2007

Trade Name Active Ingredient FDA Received Date Approval Date Total Time to Approval (months) # of Review Cycles Review Priority DEADLINE* NO DEADLINE New Boxed Warning Date FDA Link
Bextra Valdecoxib 16-Jan-01 16-Nov-01 10 1 S X   24-Nov-04 information
Rezulin Troglitazone 01-Aug-96 29-Jan-97 6 1 P X   15-Dec-97 information
Trovan Alatrofloxacin Mesylate 30-Dec-96 18-Dec-97 11.6 1 S X   09-Jun-99 information
Evista Raloxifene Hydrochloride 09-Jun-97 09-Dec-97 6 1 P X   13-Sep-07 information
Epivir Lamivudine 07-Jul-95 17-Nov-95 4.4 1 P X   15-Dec-97 information
Trovan Trovafloxacin Mesylate 30-Dec-96 18-Dec-97 11.6 1 S X   09-Jun-99 information
Xeloda Capecitabine 31-Oct-97 30-Apr-98 6 1 P X   07-Sep-01 information
Celebrex Celecoxib 30-Jun-98 31-Dec-98 6 1 P X   29-Jul-05 information
Avandia Rosiglitazone Maleate 25-Nov-98 25-May-99 6 1 P X   14-Aug-07 information
Actos Pioglitazone Hydrochloride 15-Jan-99 15-Jul-99 6 1 P X   14-Aug-07 information
Lotronex Alosetron Hydrochloride 30-Jun-99 09-Feb-00 7.4 1 P   X 07-Jun-02 information
Duract Bromfenac Sodium 30-Dec-94 15-Jul-97 27.7 3 S   X 31-Mar-98 information
Orgaran Danaparoid Sodium 30-Dec-94 24-Dec-96 23.8 3 S   X 30-Jan-98 information
Celexa Citalopram Hydrobromide 12-May-97 17-Jul-98 14.2 2 S   X 18-Feb-05 information
Zyprexa Olanzapine 22-Sep-95 30-Sep-96 12.3 2 S   X 16-Feb-06 information
Nilandron Nilutamide 07-Mar-94 19-Sep-96 30.5 3 S   X 29-Sep-00  
Remeron Mirtazapine 30-Jan-95 14-Jun-96 16.5 2 S   X 12-Jan-05 information
Invirase Saquinavir 31-Aug-95 06-Dec-95 3.2 1 P   X 14-Nov-00 information
Seroquel Quetiapine Fumarate 29-Jul-96 26-Sep-97 13.9 2 S   X 20-Sep-06 information
Optimark Gadoversetamide 02-Mar-98 08-Dec-99 21.2 2 S   X 04-Sep-07 information
Mobic Meloxicam 16-Dec-98 13-Apr-00 15.9 2 S   X 11-Aug-05 information
Geodon Ziprasidone Hydrochloride 17-Mar-97 05-Feb-01 46.7 3 S   X 17-Aug-05 information
Elidel Pimecrolimus 15-Dec-00 13-Dec-01 11.9 1 S   X 19-Jan-06 information
Abilify Aripiprazole 31-Oct-01 15-Nov-02 12.5 2 S   X 16-Feb-06 information
Strattera Atomoxetine Hydrochloride 12-Oct-01 26-Nov-02 13.5 2 S   X 08-Nov-05 information
Cymbalta Duloxetine Hydrochloride 13-Nov-01 03-Aug-04 32.7 3 S   X 18-Feb-05 information
Ketek Telithromycin 01-Mar-00 01-Apr-04 49.1 3 S   X 12-Feb-07 information
Definity Perflutren Lipid Microsphere 09-Dec-98 31-Jul-01 31.7 3 S   X 10-Oct-07 information
Tasmar Tolcapone 05-Jun-96 29-Jan-98 19.8 2 S   X 16-Nov-98 information

Complete listing of all 314 drug approvals and any corresponding new boxed warnings and safety-based withdrawals

 

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