FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
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.
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.
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 |
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 |