Comparison
Data Set: Carpenter/Zucker/Avorn (CZA) Data and Nardinelli et al Data
NDA =
New Drug Application
NME =
New Molecular Entity
SBW = Safety-based
withdrawal
BBW =
Black-box warning (added postmarket)
|
NDA Number |
NME Generic Name |
Difference between CZA Data and Nardinelli et al Data |
Notes on Discrepancy |
NME Trade Name |
Submission Date |
Approval Date |
Submission Year |
Submission Year (centered) |
Approval Time (in months) |
NME Priority |
Just-Before-Deadline Approval (original, with
rounding) |
Just-Before-Deadline Approval (without rounding) |
CZA SBW Measure |
CZA Original BBW Measure |
CZA Corrected BBW Measure, stop coding August
2005 |
CZA BBW Measure, stop coding December 2007 |
Is the NME the same in all particulars as the Nardinelli data? |
Was the NME also in the Nardinelli
et al data? |
Nardinelli
Approval Deadline Measure |
FDA Priority Rating |
Nardinelli et
al SBW |
Nardinelli et
al BBW |
Nardinelli et
al SBW, stop coding August 2005 |
Nardinelli et
al BBW, stop coding August 2005 |
Nardinelli et al
SBW, stop coding at Vioxx removal |
Nardinelli et
al BBW, stop coding at Vioxx rermoval |
Was the NME in the CZA data? |
|
20977 |
Abacavir
Sulfate |
|
|
Ziagen |
6/24/1998 |
12/17/1998 |
1998 |
18 |
5.79 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
21320 |
Abarelix |
FDA has 12/12/2000 subdate |
|
Plenaxis |
12/11/2000 |
11/25/2003 |
2000 |
20 |
35.97 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
21431 |
Acamprosate
Calcium |
|
|
Campral |
12/27/2001 |
7/29/2004 |
2001 |
21 |
31.50 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
20482 |
Acarbose |
|
|
Precose |
9/6/1994 |
9/6/1995 |
1994 |
14 |
12.00 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
20338 |
Adapalene |
|
|
Differin |
3/26/1993 |
5/31/1996 |
1993 |
13 |
38.20 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
21449 |
Adefovir Dipivoxil |
FDA has no BBW; we have BBW; also FDA has 3/21 subdate |
We code significant new information added to BBW. |
HEPSERA |
3/20/2002 |
9/20/2002 |
2002 |
22 |
6.13 |
1 |
1 |
1 |
0 |
1 |
1 |
1 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
20760 |
Alatrofloxacin Mesylate |
FDA has no SBW; has BBW 09-Jun-1999 |
Nardinelli et
al have no SBW for this but do have SBW for Orlaam,
which exits |
Trovan |
12/30/1996 |
12/18/1997 |
1996 |
16 |
11.61 |
0 |
1 |
1 |
1 |
0 |
1 |
1 |
0 |
1 |
1 |
0 |
0 |
1 |
0 |
1 |
0 |
1 |
1 |
|
20666 |
Albendazole |
|
|
Albenza |
12/11/1995 |
6/11/1996 |
1995 |
15 |
6.02 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
20560 |
Alendronate |
|
|
Fosamax |
3/31/1995 |
9/29/1995 |
1995 |
15 |
5.98 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
21287 |
Alfuzosin
Hydrochloride |
|
|
Uroxatral |
12/8/2000 |
6/12/2003 |
2000 |
20 |
30.53 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
20886 |
Alitretinoin |
FDA has 5/26/97 subdate |
|
Panretin |
5/26/1998 |
2/2/1999 |
1998 |
18 |
8.28 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
21001 |
Almotriptan Malate |
FDA has 12/20/1999 subdate |
|
Axert |
12/17/1999 |
5/7/2001 |
1999 |
19 |
16.90 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
21107 |
Alosetron HC1 |
FDA has SBW in June 2000; BBW in June 2002 |
This is CZA error, should have been included as
BBW. Nardinelli
coding is odd, however, in that it lists alosetron
as having both SBW and BBW, even though the BBW comes after the SBW |
Lotronex |
6/29/1999 |
2/9/2000 |
1999 |
19 |
7.50 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
1 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
20965 |
Aminolevulinic
acid |
|
|
Levulan Kerastick |
7/1/1998 |
12/3/1999 |
1998 |
18 |
17.10 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
20511 |
Amlexanox |
|
|
Aphthasol |
4/19/1995 |
12/17/1996 |
1995 |
15 |
19.99 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
21007 |
Amprenavir |
|
|
Agenerase |
10/16/1998 |
4/15/1999 |
1998 |
18 |
5.95 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
20333 |
Anagrelide
Hydrochloride |
|
|
Agrylin |
1/31/1996 |
3/14/1997 |
1996 |
16 |
13.41 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
20541 |
Anastrozole |
|
|
Arimidex |
3/29/1995 |
12/27/1995 |
1995 |
15 |
8.98 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
21264 |
Apomorphine
Hydrochloride |
Not in FDA data; may not be NME |
|
Apokyn |
12/31/2002 |
4/20/2004 |
2002 |
22 |
15.87 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
21549 |
Aprepitant |
|
|
Emend |
9/27/2002 |
3/26/2003 |
2002 |
22 |
6.00 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
20420 |
Arbutamine
Hydrochloride |
FDA has 1/6/1994 subdate |
|
Genesa |
12/20/1993 |
9/12/1997 |
1993 |
13 |
44.78 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
20883 |
Argatroban |
FDA has 8/15/1997 subdate |
|
Acova |
8/11/1997 |
6/30/2000 |
1997 |
17 |
35.13 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
21436 |
Aripiprazole |
FDA has BBW Feb 2006 |
BBW added after CZA stopped coding. This is a
class relabeling. |
Abilify |
10/31/2001 |
11/15/2002 |
2001 |
21 |
12.67 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
|
21248 |
Arsenic Trioxide |
FDA has 3/28/2000 subdate |
|
Trisenox |
3/27/2000 |
9/25/2000 |
2000 |
20 |
6.07 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
20971 |
Articaine HCl 4%; Epinephrine |
|
|
Septocaine |
3/30/1998 |
4/3/2000 |
1998 |
18 |
24.50 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
21567 |
Atazanavir
Sulfate |
|
|
Reyataz |
12/20/2002 |
6/20/2003 |
2002 |
22 |
6.07 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
21411 |
Atomoxetine
Hydrochloride |
FDA has BBW Nov 2005 |
BBW added after CZA stopped coding; also a
therapeutic class relabeling. |
Strattera |
10/11/2001 |
11/26/2002 |
2001 |
21 |
13.70 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
|
20702 |
Atorvastatin
Calcium |
|
|
Lipitor |
6/17/1996 |
12/17/1996 |
1996 |
16 |
6.02 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
50794 |
Azacitidine |
FDA has 12/29/03 as subdate |
|
Vidaza |
12/26/2003 |
5/19/2004 |
2003 |
23 |
4.83 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
20428 |
Azelaic
acid |
|
|
Azelex |
2/28/1994 |
9/13/1995 |
1994 |
14 |
18.48 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
20610 |
Balsalazide Disodium |
|
|
Colazal |
6/23/1997 |
7/18/2000 |
1997 |
17 |
37.37 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
20532 |
Bentoquatam |
FDA has 9/29/94 subdate |
|
Ivy Block |
9/28/1994 |
8/26/1996 |
1994 |
14 |
22.95 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
20576 |
Betaine
anhydrous |
|
|
Cystadane |
10/25/1995 |
10/25/1996 |
1995 |
15 |
12.03 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
21055 |
Bexarotene |
FDA has as no predead
approval; this fits our two week rule |
Targretin |
6/23/1999 |
12/29/1999 |
1999 |
19 |
6.21 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
|
20498 |
Bicalutamide |
|
|
Casodex |
9/14/1994 |
10/4/1995 |
1994 |
14 |
12.66 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
||||