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89 documents found matching dt:chart.
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of 9
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Showing 1-10 of 89 documents
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1.
Medicaid Expenditures for Off-Label Neurontin [and other Neurontin-related slides]
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Document Date:
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00000000
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Search Terms in Context:
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pgNbr=1
Medicaid Expenditures for Off-label Neurontin
yj'tW Y'rtf' r)hi' 3' ~4'Sgje[ * If, ," 2`h &S
3~.?T
~i'+~ ~r~` np "~~,. it 4' ""k_v~, y ~r',~P~ f" ~ ~.S~t iuL~ ~Fs4rn.' ~ ~ ~~~ ~ ~'~_ ~ ~~- `
7r~ v Diabetic Peripheral $3,381,957
Neuropathy
~
'~ '. u~.,°' x_'`f "~`~r.3' , ~ Y~4 0 ~it~~ ~"?,, f _ ,ice.. " _..:;®®®® S 7 ,~ ~'~.'`~
~' r
r H r Postherpetic $3,140,621
Neuralgia
~~tA 'ff r~ AffY ~'3q'M'~1' ~~" b I l 4 ..r y t ~`Sn __
1 V PlL YG_L
5 y~~3.
l
~ ,bye '. ~~*k .
////" Paln $199,003,319 shq
y '~A.0 A.r 3 ! ~'G
ry 'wt, ~ ~` ,t' , ~ .gyn.} ~ 4t: ~p ~ `~' ~s y :'.
u w ~+ n '` s Y tci J
~~ d ~~ r-k ~ M; x./.t ~'~'i~FS ~ ~ y '~``R?. d ~ t k~ Ir :~Y~S
~}C`:r++4C~ °i'v {,~'
Other $ 83,673,540
1000
900
800
100
0
200
O Pain
^ D
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http://dida.library.ucsf.edu/tid/qdb00a10
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2.
VIGOR MIs Over Time (chart)
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Document Date:
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00000000
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Search Terms in Context:
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VIGOR: Myocardial Infarctions Over Time
• Individual events labeled by study day
• Heavy outline = aspirin-indicated patient
• Above timeline = VIOXX
• Below timeline = naproxen
30 17
41
5
6
4
5
90
101
163
I4!
14sl
193
179
264
264
305
257
288
257
283
322
42
79
167
Day
100
200
300
pgNbr=1
VIGOR: Unstable Angina Over Time
• Individual events labeled by study day
• Heavy outline = aspirin-indicated patient
• Above timeline = VIOXX
• Below timeline = naproxen
32
E
67
Day
96
152
17
38
253
1
200
pgNbr=2
VIGOR: Non-Hemorrhagic Strokes Over Time
• Individual events labeled by study day
• Heavy outline = aspirin-indicated patient
• Above timeline = VIOXX
• Below timeline = naproxen
19
42
Day
133
132
91
123
160
279
254
294
I
25
61
165
201
239
282
30 |
i
216
i
100
200
300
pgNbr=3
VIGOR: Peripheral Th
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http://dida.library.ucsf.edu/tid/oxx14j10
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3.
Neurontin: Gabapentin Capsules - Lifecycle Update
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Document Date:
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19970709
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Search Terms in Context:
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pgNbr=1
V056395
pgNbr=2
oHH
Fvi 'TACTICS
Mcr- p 3ETtrnmars.t
Vic
NEURONTIN'
gabapentin capsules
Lifecycle Update
July 9, 1997
pgNbr=3
Neurontin Lifecycle
409
3.o 3so 10o
1 so
l o0
so
U.S. SMM 0 (49^Llfe Cycle
- o
A 1999
ist .available
1998 / tup.
Ist oge I'
e~866mi15% syntp
2nd
1800mg tabs
1997 4th r
2nd Quarter cdiauics indication
1996 - STEPS results announced 2000
4th Quarter - Submit 600mg/800mg tabs
- Monothcrapy sNDA 3rd Quarter st Quarter
submitted - Monotx trial results announced manIatc, 000)
ith Quarter cxpi Ilan 16, 2000)
-DPN, PIN study results
announced
- Monobt indication/launch
- Submit pediatric NDA
1995 1 MM paticnt starts
1st Quarter
_ CTFPC iai,nrhrd
1994
-Launch Feb. l)
I o04 IS 004 - 1003 1 099 - I too taco _
roof
40.5 01.0 311.3 540.1 330 171.9 164 .E 111.3
ion
pgNbr=4
Neurontin Lifecycle Update
Publications
STEPS - manuscript end of 3Q97
Dose Initiation Study
-- Abstract (AES) - "Efficacy of gabapentin as add-on for patients
over
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4.
Neurontin Average Daily Dosing for Epilepsy/Convulsion
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Document Date:
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19970820
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Author:
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Price, Eric
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Corporate Author:
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Scott-Levin
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Search Terms in Context:
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pgNbr=1
CONFIDENTIAL
Scott - Levin
Memo
To Men Crook, Jahn Knoop, Rids Wantiez, Sue Chandler From Eric Price (Scott-Levin) .
CO Bruce Kestenbaum, Flavia Brock
Data oaria97
Rae Neurontin Average Daily Dosing for Epilepsy/Convulsion
In response to the recent questions concerning the drop in Neurontin's average daily dosing for epilepsy/convulsions, we ran the data by physician specialty. Neurologists accounted for 87% of the 300 mg uses and 76% of the 400 mg uses during subsequent visits in the six months ending June 1997. There were no 100 mg uses captured from Neurologists for subsequent visits during this time period. The outlying data from other specialties, although minimal, was driving down the average dailyy dose.
Therefore, a more accurate method to measure Neurontin use for epilepsy/convulsion is to also fitter for Neurologists. This reveals the average daily dose has been rising. In fact, the average dose of Neurontin for epilepsy convulsions was 1827 mg for the six months ending June 1997.
The at
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5.
Neurontin 1996 SE CBU Plan, Goal: 12% N Rx by December 1996
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Document Date:
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19960000/e
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Search Terms in Context:
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pgNbr=1
~ONTIN 199 SE Ull PLAN
GOAL: 12% NRx BYDECEMBER 1996
TARGET CU, TOMERS:
EPILEPSY EPILEPSY CENTERS/ TEACHING
HOSPITALS
ADULT COMMUNITY NEUROLOGISTS
PEDIATRIC COMMUNITY NEUROLOGISTS
DECILE 8-10 PRIMARY CARE DOCTORS
MEDICAL AFFAIRS/ PAIN CENTERS
MD INTERACTION PSYCHIATRISTS
PRIMARY CARE DOCTORS
COMMUNITY NEUROLOGISTS
STRATEGIES/TA TICS:
1. EPILEPSY
A. MEDICAL EDUCATION DRIVES THIS MARKET!!
SPRING 1996 CAMPAIGN SCHEDULE:
2/4/96 MARCO ISLAND, FL 100 ADULT NEUROS
2/8/96
3/10/96 HUTCHINSON ISLAND, FL 80 PEDIATRIC NEUROS
2196-5/96 15 DISTRICT MEETINGS -400 NEUROS
TOTAL: --600 NEUROLOGISTS
PLUS PLAN PROGRAM4/ACTIVITIES
FALL 15 DISTRICT MEETINGS -400 NEUROS
FALL PEDIATRIC NEURO SPEAKER
PROGRAMS/C. CALLS
-100 PED NEUROS
TOTAL: -500 NEUROS
W 003095
pgNbr=2
B. SELLING MESSAGE
NEURONTIN, WHEN TITRATED TO EFFECT, IS THE SAFEST AND
EASIEST AED TO USE IN STOPPING SEIZURES AND SIDE EFFECTS. ANY
PATIENT WHO IS NOT SEIZURE OR SIDE EFFECT FREE IS A NEURONTIN
PATIENT.
C. KEY SELLING POINTS
* > 140,000 PA
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6.
Parke-Davis Pharmaceutical-Sector - 1998 Operating Plan: USA Neurontin
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Document Date:
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19980000/e
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Corporate Author:
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Parke-Davis
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Search Terms in Context:
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CONFIDENTIAL
Pharmaceutical-Sector 1998 Operating Plan-
1997 OP 1997 LE 1998 OP
$1312 $1462 $1686
+16.0% +29.3% +15.3%
$260.2 $248.1 $358.3
+29.8% +23.9% +44.4%
19.8% 17.0% 21.3%
9.2% 10.2% 13.3%
30.1% 28.7% 25.4%
NIA 23.9% 25.0%
N/A 10.6% 8.0%
N/A 11.3% 10.3%
Neurontih has received an unexpected delay in its monotherapy indication approval. Subsequently, Parke-Davis has appealed the FDA decision to the division head, Dr. Robert Temple, M.D. While awaiting the outcome of Dr. Temple's decision, PD will accelerate obtaining the results of the U.S. monotherapy trial (945-213) by ending this study in Feb'98. Although this is ahead of schedule, we will have the majority of the targeted enrollment levels achieved and we believe we will have enough power to generate the desired results. Re-submission with this additional data to FDA is expected in June '98. An approved indication is expected by December '98, which is considered the best case scenario (unless the Temple appeal proves successful).
P-D will overcome th
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7.
1994 Merritt Putnam Lectures Topline Promotrak Analysis
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Document Date:
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19940000/e
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Author:
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Guerrero, Edda
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Search Terms in Context:
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of the Merritt Putnam Lectures include public relations within the neurology community, etc., as well as impacting the volume of Neurontin new prescriptions.
Of the total number of attendees (897), the specialties of 583 (65%) were able to be identified (314, or 35%, were not able to be identified). Of the 65%, close to half (48%) were neurologists/child neurologists. (See the attached chart
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8.
Supplemental New Drug Application 21-042: Rofecoxib - VIGOR
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Document Date:
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20000629
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Author:
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Erb, Dennis
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Corporate Author:
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Merck & Co., Inc
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Search Terms in Context:
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Table Of Contents For Supplemental NDA 21-042 (n/a = not Rofecoxib - VTGOR applicable)
Item
Description
Paper archive copy volume number
Electronic archive folder
1
Table Of Contents (Index)
1
main folder
2
Labeling
n/a
labeling
3
Summary
n/a
summary
4
Chemical and Pharmaceutical Manufacturing and Controls
n/a
n/a
5
Nonclinical Pharmacology And Toxicology Section
n/a
n/a
6
Human Pharmacokinetics & Bioavailability/Bioequivalence
n/a
n/a
7
Clinical Microbiology
n/a
n/a
8
Clinical
n/a
clinstat
9
Safety Update Report
n/a
n/a
10
Statistical
n/a
clinstat
11
Case Report Tabulations
n/a
crt
12
Case Report Forms
n/a
erf
13
Patent Information
n/a
n/a
14
Patent Certification
n/a
n/a
15
Establishment Description
n/a
n/a
16
Debarment Certification
1
other
17
Field Copy Certification
n/a
n/a
18
User Fee Cover Sheet
1
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9.
[Memo regarding the latest version of the manuscript for Protocol 023]
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Document Date:
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19980218
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Author:
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Morrison, Briggs W
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Corporate Author:
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Merck & Co., Inc
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Search Terms in Context:
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MEMO
MERCK
Research Laboratories
TO: Alan Nies 4W *W 40W
Barry Gertz Beth Seidenberg Hui Quan Jim Bolognese
CC:
FROM: Briggs SUBJECT:
DATE: 2/18/98
Attached is the latest version of manuscript for Protocol 023. The cover letter summarizes the changes made from last version. Please take a look and let me know what you think. I have also sent a copy to Ifen Lasseter since he is an author as well.
+
You will see that some of the phrasing is not what we had suggested. The last sentence of the abstract, for example, was previously revised but has reverted. They also still use the wording "systemic biosynthesis of prostacyclin".
I would like to first receive comments from all. Depending on the intensity of "discomfort" with the present wording, we may need to have a teleconference with the folks at Penn to resolve any issues.
Documcnt4
PI.1184
Confidential - Subject To Protective Order
MRK-NJ0017794
pgNbr=1
Briggs W Morrison Associate Director P
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10.
[Tables 18 - 32, Figures 9 - 14]
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Document Date:
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00000000
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Search Terms in Context:
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Table 18 Analysts of Prespecified Adverse Expérience Categories
1
Treatment Group
N
1 ~I
Partíais
with
Events
1
PYX'
1 ....."
Kates1
1
Rfiiatlve Risk*
I
Type of Adverse Experieoce
Estimate
1 95% Cf
1 p-valne
Serious clinical AEs
RofecQKJb Naproxen
4052 4031
290 242
2699 2703
10.74 8.95
1.20
(1.01, 1.42)
0.037
Drag-re!3ted clinical AEs
Rofecoxib
Naproxen
4052 +031
1286 1332
2234 2222
57.58 59.93
0.96
(0.89. 1.04)
0.307
Clmical AEs leading to discontinuation
Rofecoxib Naproxen
4052 4031
tío*
587
2727 2718
22.15 21.60
1.03
(0.92, 1.15)
0.S57
Discons due to GI AEs + abdomiial paia Rofecoxib
NaDTOxen
4052 4031
295 3S5
2750 2733
10.73 14.09
0.76
(0.65, 0.89) <0.001
DisconS dite to edema-relataf AEs
Rofecoxib
Naproxen
4052 4031
24 14
2770 2762
0.87 051
1.71
(0.88, 3.30) 0.111
Discons due to hypertension-related AEs
Rofecoxib Naproxen
4052 4031
23 5
2770 2763
0.83 0.1S
4.58
(1.74, 1204)
0.002
Discons
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