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Center for Drug Evaluation and Research

Office of Generic Drugs

Monthly Quantitative Report


and Statistical Charts
July 2005
M E M O R A N D U M DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
OFFICE OF GENERIC DRUGS

DATE: August 11, 2005

FROM: LCDR Martin Shimer


Branch Chief
Division of Labeling and Program Support

THROUGH: Peter Rickman


Director
Division of Labeling and Program Support

SUBJECT: Statistical Report – Month of July 2005

TO: See Below

This memorandum represents the Office of Generic Drugs'


statistical report for July 2005.

Tables I through III detail quantitative information about OGD's


receipts, actions, and pending review status for both original
and supplemental (CMC and labeling) applications for the past
month and for the 11 preceding months. Following the tables,
graphic presentations of selective quantitative data are
provided. In addition three new strength supplements were
approved. These graphs allow comparisons to similar data dating
back to 1998.

Approvals for the month of July include 29 new generic full


approvals and 14 tentative approvals. Of the 43 approvals, 15
applications were approved as first generics. Separate lists of
the approvals for the month of July follow the graphic
presentations.

cc:
Center for Drug Evaluation and Research - Office of Generic Drugs Table I
Quantitative Report

ORIGINAL APPLICATIONS
AVG AVG AVG
Aug-04 Sep-04 Oct-04 Nov-04 Dec-04 Jan-05 Feb-05 Mar-05 Apr-05 May-05 Jun-05 Jul-05 TOTAL LAST 12 LAST 3 PRIOR
MOS MOS YEAR

-- RECEIPTS --

TOTAL ORIGINALS 47 45 70 73 113 55 66 85 41 39 55 73 762 64 56 44

AMENDMENTS 285 259 282 264 273 231 222 299 308 292 296 312 3323 277 300 234

- MAJOR 121 117 140 119 117 109 123 149 148 163 145 143 1594 133 150 115

- MINOR 164 142 142 145 156 122 99 150 160 129 151 169 1729 144 150 119

-- ACTIONS --

APPROVALS 22 31 45 28 42 20 9 24 41 30 27 29 348 29 29 28

TENTATIVE APPROVALS+ 6 10 9 5 11 6 7 11 2 6 12 14 99 8 11 8

APPROVABLE+ 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

NOT APPROVABLE 68 78 55 87 64 79 86 102 63 106 110 65 963 80 94 77

REFUSE TO RECEIVE 6 5 5 8 10 60 10 12 16 7 9 8 156 13 8 6

WITHDRAWALS 3 6 12 23 6 5 5 7 7 3 35 2 114 10 13 9

- OF APPROVED 0 0 2 17 3 3 2 3 1 0 25 2 58 5 9 7

- OF UNAPPROVED 3 6 10 6 3 2 3 4 6 3 10 0 56 5 4 3

-- REVIEW STATUS --
AWAITING OGD ACTION
(TOTAL)*** 607 615 646 665 733 748 767 810 817 802 794 842 737 813 580
AWAITING OGD ACTION (>
180 DAYS)*** 64 71 82 85 95 95 99 104 117 144 158 140 105 147 62
AWAITING OGD ACTION (<
180 DAYS)*** 543 544 564 580 638 653 668 706 700 658 636 702 633 665 518

*** In September, 1991, the Office of Generic Drugs started implementation of its Application Integrity Policy by suspending
review of applications suspected of being tainted by fraud. Review status figures reported since this date exclude
suspended applications. As of July 31, 2005, 2 original application and 0 supplements were suspended.
Upon completion of validity assessments, suspended applications may be returned to active pending status.
+ Note: Approvable and Tentative approvals are counted as approvals subsequently when approved.
Center for Drug Evaluation and Research - Office of Generic Drugs Table II
Quantitative Report

POST APPROVAL SUBMISSIONS TO APPLICATIONS (CHEMISTRY)


AVG AVG AVG
Aug-04 Sep-04 Oct-04 Nov-04 Dec-04 Jan-05 Feb-05 Mar-05 Apr-05 May-05 Jun-05 Jul-05 TOTAL LAST 12 LAST 3 PRIOR
MOS MOS YEAR
--RECEIPTS--

ORIGINAL SUPPLEMENTS 487 231 279 341 240 240 256 468 226 257 213 201 3439 287 224 281
AMENDMENTS TO
SUPPLEMENTS 660 244 321 430 280 337 336 528 292 272 232 254 4186 349 253 329

--SUPPLEMENTAL ACTIONS--

APPROVALS 338 530 194 217 258 238 340 363 184 263 157 170 3252 271 197 232
APPROVABLE 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
NOT APPROVABLE 76 63 91 110 68 77 65 64 26 49 29 39 757 63 39 84
WITHDRAWALS 10 12 10 10 5 13 7 17 0 12 7 3 106 9 7 11

--REVIEW STATUS--

SUPPLEMENTS AWAITING
OGD ACTION (TOTAL) 1781 1444 1497 1586 1530 1548 1465 1567 1644 1490 1809 1809 1598 1703 1469
SUPPLEMENTS AWAITING
OGD ACTION (>180 DAYS) 118 109 163 165 157 186 201 173 197 222 219 348 188 263 80
SUPPLEMENTS AWAITING
OGD ACTION (<=180 DAYS) 1663 1335 1334 1418 1373 1362 1264 1394 1447 1268 1590 1456 1409 1438 1389
Center for Drug Evaluation and Research - Office of Generic Drugs Table III
Quantitative Report

POST APPROVAL SUBMISSIONS TO APPLICATIONS (LABELING)


AVG AVG AVG
Aug-04 Sep-04 Oct-04 Nov-04 Dec-04 Jan-05 Feb-05 Mar-05 Apr-05 May-05 Jun-05 Jul-05 TOTAL LAST 12 LAST 3 PRIOR
MOS MOS YEAR
--RECEIPTS--

ORIGINAL SUPPLEMENTS 50 77 51 40 48 43 74 123 97 68 39 67 777 65 58 58


AMENDMENTS TO
SUPPLEMENTS 80 81 72 47 53 68 87 146 112 90 56 92 984 82 79 70

--SUPPLEMENTAL ACTIONS-

APPROVALS 40 55 77 32 43 41 21 44 110 85 93 92 733 61 90 49


APPROVABLE 1 0 0 0 6 0 0 8 8 7 5 6 41 3 6 3
NOT APPROVABLE 4 4 6 40 7 5 2 9 8 5 4 6 100 8 5 9
WITHDRAWALS 0 1 2 0 1 4 0 0 6 6 5 0 25 2 4 3

--REVIEW STATUS--

SUPPLEMENTS AWAITING
OGD ACTION (TOTAL) 389 415 384 389 389 393 473 524 477 451 408 338 419 399 364
SUPPLEMENTS AWAITING
OGD ACTION (>180 DAYS) 133 138 128 134 164 169 186 187 135 121 110 95 142 109 118
SUPPLEMENTS AWAITING
OGD ACTION (<=180 DAYS) 256 277 256 255 225 224 287 337 342 330 298 243 278 290 246
Office of Generic Drugs ANDA Full Approvals
For Month of July 2005
1 . 40-594 MERCAPTOPURINE TABLETS USP,
50 MG
MYLAN PHARMACEUTICALS, INC.
AP'd on: 7/1/2005
2 . 76-470 DESMOPRESSIN ACETATE TABLETS,
0.1 MG AND 0.2 MG
BARR LABORATORIES, INC.
AP'd on: 7/1/2005
3 . 40-648 ISONIAZID INJECTION USP,
100 MG/ML; 10 ML VIALS
SABEX 2002 INC.
AP'd on: 7/5/2005
4 . 40-498 DIPHENHYDRAMINE HYDROCHLORIDE INJECTION USP,
50 MG/ML; 10 ML VIALS
BIONICHE PHARMA
AP'd on: 7/12/2005
5 . 40-619 METHIMAZOLE TABLETS USP,
15 MG
CEDAR PHARMACEUTICALS LLC
AP'd on: 7/12/2005
6 . 76-973 ALCLOMETASONE DIPROPIONATE CREAM USP,
0.05%
ALTANA INC.
AP'd on: 7/12/2005
7 . 77-142 METHADONE HYDROCHLORIDE TABLETS USP,
40 MG
MALLINCKRODT INC.
AP'd on: 7/12/2005
8 . 65-228 AMOXICILLIN TABLETS USP,
500 MG AND 875 MG
SANDOZ INC.
AP'd on: 7/13/2005
9 . 76-169 FEXOFENADINE HYDROCHLORIDE CAPSULES,
60 MG
BARR LABORATORIES, INC.
AP'd on: 7/13/2005
10 . 77-005 HYDROCHLOROTHIAZIDE CAPSULES,
12.5 MG
IVAX PHARMACEUTICALS, INC.
AP'd on: 7/13/2005
Full Approvals Page 1
11 . 77-074 LORAZEPAM INJECTION USP (PRESERVATIVE-FREE),
2 MG/ML AND 4 MG/ML; 1 ML VIALS
BEDFORD LABORATORIES
AP'd on: 7/13/2005
12 . 77-076 LORAZEPAM INJECTION USP,
2 MG/ML AND 4 MG/ML; 10 ML VIALS
BEDFORD LABORATORIES
AP'd on: 7/13/2005
13 . 76-834 BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP,
150 MG
SANDOZ INC.
AP'd on: 7/14/2005
14 . 76-845 BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP,
100 MG AND 150 MG
SANDOZ INC.
AP'd on: 7/14/2005
15 . 40-582 FOLIC ACID TABLETS USP,
1 MG
MUTUAL PHARMACEUTICAL COMPANY, INC.
AP'd on: 7/18/2005
16 . 76-884 ALCLOMETASONE DIPROPIONATE OINTMENT USP,
0.05%
ALTANA INC.
AP'd on: 7/18/2005
17 . 77-114 IBUPROFEN TABLETS USP,
400 MG, 600 MG, AND 800 MG
PERRIGO R&D COMPANY
AP'd on: 7/18/2005
18 . 77-072 IPRATROPIUM BROMIDE INHALATION SOLUTION,
0.02%
RxELITE
AP'd on: 7/19/2005
19 . 77-151 MILRINONE LACTATE IN 5% DEXTROSE INJECTION,
20 MG (BASE)/100 ML; 100 ML AND 200 ML PLASTIC CONTAINERS
APOTEX CORP.
AP'd on: 7/20/2005
20 . 40-625 FOLIC ACID TABLETS USP,
1 MG
PHARMAX GROUP, INC.
AP'd on: 7/21/2005

Full Approvals Page 2


21 . 76-705 RANITIDINE TABLETS USP,
150 MG AND 300 MG
DR. REDDY'S LABORATORIES LIMITED
AP'd on: 7/27/2005
22 . 77-352 FAMOTIDINE TABLETS USP,
20 MG AND 40 MG
PERRIGO R&D COMPANY
AP'd on: 7/27/2005
23 . 40-601 BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLETS USP,
50 MG/325 MG/40 MG
MUTUAL PHARMACEUTICAL COMPANY, INC.
AP'd on: 7/29/2005
24 . 65-166 CEFUROXIME AXETIL TABLETS USP,
125 MG (BASE), 250 MG (BASE), AND 500 MG (BASE)
WOCKHARDT LIMITED
AP'd on: 7/29/2005
25 . 65-221 RIFAMPIN AND ISONIAZID CAPSULES USP,
300 MG/150 MG
WEST-WARD PHARMACEUTICAL CORP.
AP'd on: 7/29/2005
26 . 76-915 DESOGESTREL AND ETHINYL ESTRADIOL TABLETS,
0.15 MG/0.03 MG (28-DAY)
WATSON LABORATORIES, INC.
AP'd on: 7/29/2005
27 . 77-105 VALPROIC ACID SYRUP USP,
250 MG/5 ML
APOTEX INC.
AP'd on: 7/29/2005
28 . 77-121 BACLOFEN TABLETS USP,
20 MG
ALPHAPHARM PTY. LTD.
AP'd on: 7/29/2005
29 . 77-181 BACLOFEN TABLETS USP,
10 MG
ALPHAPHARM PTY. LTD.
AP'd on: 7/29/2005

Full Approvals Page 3


Office of Generic Drugs ANDA Tentative Approvals
For Month of July 2005
1 . 77-672 STAVUDINE CAPSULES USP, 30 MG AND 40 MG
AUROBINDO PHARMA LIMITED
TA'd 7/1/2005
2 . 77-558 LAMIVUDINE AND ZIDOVUDINE TABLETS, 150 MG/300 MG
AUROBINDO PHARMA LTD.
TA'd 7/6/2005
3 . 76-715 MODAFINIL TABLETS, 100 MG AND 200 MG
CARLSBAD TECHNOLOGY, INC.
TA'd 7/13/2005
4 . 77-327 ZIDOVUDINE TABLETS USP, 300 MG
RANBAXY LABORATORIES LIMITED
TA'd 7/13/2005
5 . 76-914 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS, 37.5 MG/325
MG
TEVA PHARMACEUTICALS USA
TA'd 7/18/2005
6 . 76-447 FEXOFENADINE HYDROCHLORIDE TABLETS, 30 MG, 60 MG, AND 180 MG
TEVA PHARMACEUTICALS, USA
TA'd 7/19/2005
7 . 76-875 GLIMEPIRIDE TABLETS, 1 MG, 2 MG, 4 MG, AND 8 MG
RANBAXY LABORATORIES LIMITED
TA'd 7/20/2005
8 . 76-944 SERTRALINE HYDROCHLORIDE TABLETS, 25 MG (BASE), 50 MG (BASE), AND
100 MG (BASE)
ANDRX PHARMACEUTICALS, LLC
TA'd 7/21/2005
9 . 76-844 ZIDOVUDINE TABLETS USP, 300 MG
ROXANE LABORATORIES, INC.
TA'd 7/27/2005
10 . 77-366 GLIMEPIRIDE TABLETS, 3 MG AND 6 MG
RANBAXY LABORATORIES LIMITED
TA'd 7/27/2005
11 . 77-009 ONDANSETRON ORAL SOLUTION USP, 4 MG/5 ML
TARO PHARMACEUTICAL INDUSTRIES, LTD.
TA'd 7/28/2005

Tentative Approvals Page 1


12 . 76-554 SUMATRIPTAN SUCCINATE TABLETS, 25 MG (BASE) AND 50 MG (BASE)
RANBAXY LABORATORIES LIMITED
TA'd 7/29/2005
13 . 76-572 SUMATRIPTAN SUCCINATE TABLETS, 100 MG (BASE)
RANBAXY LABORATORIES LIMITED
TA'd 7/29/2005
14 . 76-933 SUMATRIPTAN SUCCINATE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100
MG (BASE)
COBALT PHARMACEUTICALS, INC.
TA'd 7/29/2005

Tentative Approvals Page 2


Office of Generic Drugs - First Generic Approvals
77-672 STAVUDINE CAPSULES USP, 30 MG AND 40 MG
AUROBINDO PHARMA LIMITED
Submitted: 4/6/2005
Innovator BRISTOL MYERS SQUIBB CO. PHARMACEUTICAL RESEARCH
INSTITUTE
RLD: ZERIT CAPSULES
TENTATIVELY APPROVED: 7/1/2005
* * * * * * *
77-558 LAMIVUDINE AND ZIDOVUDINE TABLETS, 150 MG/300 MG
AUROBINDO PHARMA LTD.
Submitted: 2/4/2005
Innovator GLAXOSMITHKLINE
RLD: COMIVIR TABLETS
TENTATIVELY APPROVED: 7/6/2005
* * * * * * *
77-327 ZIDOVUDINE TABLETS USP, 300 MG
RANBAXY LABORATORIES LIMITED
Submitted: 10/22/2004
Innovator GLAXOSMITHKLINE
RLD: RETROVIR TABLETS
TENTATIVELY APPROVED: 7/13/2005
* * * * * * *
76-447 FEXOFENADINE HYDROCHLORIDE TABLETS, 30 MG, 60 MG, AND 180 MG
TEVA PHARMACEUTICALS, USA
Submitted: 7/1/2002
Innovator AVENTIS PHARMACEUTICALS, INC.
RLD: ALLEGRA TABLETS
TENTATIVELY APPROVED: 7/19/2005
* * * * * * *
76-554 SUMATRIPTAN SUCCINATE TABLETS, 25 MG (BASE) AND 50 MG (BASE)
RANBAXY LABORATORIES LIMITED
Submitted: 12/4/2002
Innovator GLAXOSMITHKLINE
RLD: IMITREX TABLETS
TENTATIVELY APPROVED: 7/29/2005
* * * * * * *
76-572 SUMATRIPTAN SUCCINATE TABLETS, 100 MG (BASE)
RANBAXY LABORATORIES LIMITED
Submitted: 12/17/2002
Innovator GLAXOSMITHKLINE
RLD: IMITREX TABLETS
TENTATIVELY APPROVED: 7/29/2005
* * * * * * *

First Generic Approvals


76-470 DESMOPRESSIN ACETATE TABLETS, 0.1 MG AND 0.2 MG
BARR LABORATORIES, INC.
Submitted: 8/1/2002
Innovator AVENTIS PHARMACEUTICAL PRODUCTS, INC.
RLD: DDAVP TABLETS
APPROVED: 7/1/2005
* * * * * * *
40-648 ISONIAZID INJECTION USP, 100 MG/ML; 10 ML VIALS
SABEX 2002 INC.
Submitted: 2/2/2005
Innovator SANDOZ INC.
RLD: NYDRAZID INJECTION
APPROVED: 7/5/2005
* * * * * * *
40-619 METHIMAZOLE TABLETS USP, 15 MG
CEDAR PHARMACEUTICALS LLC
Submitted: 8/24/2004
Innovator GENPHARM INC.
RLD: METHIMAZOLE TABLETS, USP
APPROVED: 7/12/2005
* * * * * * *
76-973 ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05%
ALTANA INC.
Submitted: 12/22/2003
Innovator GLAXOSMITHKLINE
RLD: ACLOVATE CREAM
APPROVED: 7/12/2005
* * * * * * *
76-169 FEXOFENADINE HYDROCHLORIDE CAPSULES, 60 MG
BARR LABORATORIES, INC.
Submitted: 5/11/2001
Innovator AVENTIS PHARMACEUTICALS, INC.
RLD: ALLEGRA CAPSULES
APPROVED: 7/13/2005
* * * * * * *
65-070 S- DOXYCYCLINE TABLETS, 150 MG
PAR PHARMACEUTICAL, INC.
Submitted: 12/17/2004
Innovator OCLASSEN PHARMACEUTICALS, INC.
RLD: MONODOX CAPSULES
APPROVED: 7/14/2005
* * * * * * *
65-055 S- DOXYCYCLINE CAPSULES USP, 150 MG
PAR PHARMACEUTICAL, INC.
Submitted: 12/17/2004
Innovator
RLD:
APPROVED: 7/15/2005
* * * * * * *

First Generic Approvals


40-512 S- PYRIDOSTIGMINE BROMIDE TABLETS USP, 30 MG
BARR LABORATORIES, INC.
Submitted: 12/19/2003
Innovator SOLVAY PHARMACEUTICALS
RLD: PYRIDOSTIGMINE BROMIDE TABLETS USP, 30 MG
APPROVED: 7/20/2005
* * * * * * *
65-221 RIFAMPIN AND ISONIAZID CAPSULES USP, 300 MG/150 MG
WEST-WARD PHARMACEUTICAL CORP.
Submitted: 4/5/2004
Innovator AVENTIS PHARMACEUTICALS, INC.
RLD: RIFAMATE CAPSULES
APPROVED: 7/29/2005
* * * * * * *

First Generic Approvals


Office Of Generic Drugs Supplement Approvals
Page 1 Wednesday, August 10, 2005

1 . 65-070 DOXYCYCLINE TABLETS, PAR PHARMACEUTICAL, 7/14/2005


S-009 150 MG INC.

2 . 65-055 DOXYCYCLINE CAPSULES PAR PHARMACEUTICAL, 7/15/2005


S-006 USP, 150 MG INC.

3 . 40-512 PYRIDOSTIGMINE BROMIDE BARR LABORATORIES, INC. 7/20/2005


S-002 TABLETS USP, 30 MG
Original ANDAs Received
110

100

90

80
Number of Submissions

70

60

50

40

30

20

10
O D F A J A O D F A J A O D F A J A O D F A J A O D F A J A O D F A J
99 99 00 00 00 00 00 00 01 01 01 01 01 01 02 02 02 02 02 02 03 03 03 03 03 03 04 04 04 04 04 04 05 05 05

by Month/Year
July 2005
Actions on Original ANDAs
160
Approvals Tentative Approvals FAX Amendments
Approvables Not Approvable

140

120

100

80

60

40

20

0
O D F A J A O D F A J A O D F A J A O D F A J A O D F A J A O D F A J
99 99 00 00 00 00 00 00 01 01 01 01 01 01 02 02 02 02 02 02 03 03 03 03 03 03 04 04 04 04 04 04 05 05 05
Note: Tentative Approvals (TA) are applications that have been approved by the office pending patent expiration. TAs and
Approvables(AE) are counted as approvals subsequently when approved. July 2005
Original ANDAs Approved or Tentatively Approved
70
Approvables

Tentative Approvals
60
Approvals

50

40

30

20

10

0
O D F A J A O D F A J A O D F A J A O D F A J A O D F A J A O D F A J
99 99 00 00 00 00 00 00 01 01 01 01 01 01 02 02 02 02 02 02 03 03 03 03 03 03 04 04 04 04 04 04 05 05 05

Note: Tentative Approvals (TA) are applications that have been approved by the office pending patent expiration. TAs and Approvables (AE)
are counted as approvals subsequently when approved.
Original ANDAs Pending Per Month
900

850 > 180 days < 180 days

800

750

700

650

600

550

500

450

400

350

300

250

200

150

100

50

0
O D F A J A O D F A J A O D F A J A O D F A J A O D F A J A O D F A J
99 99 00 00 00 00 00 00 01 01 01 01 01 01 02 02 02 02 02 02 03 03 03 03 03 03 04 04 04 04 04 04 05 05 05
Chemistry, Manufacturing & Controls Supplements
Awaiting OGD Action
2000
> 180 Days < 180 Days

1750

1500

1250

1000

750

500

250

0
O D F A J A O D F A J A O D F A J A O D F A J A O D F A J A O D F A J
99 99 00 00 00 00 00 00 01 01 01 01 01 01 02 02 02 02 02 02 03 03 03 03 03 03 04 04 04 04 04 04 05 05 05
Please note that abrupt changes in the level of pending supplements are the result of global submissions to all applications held by a single
firm. Changes other than these will be explained separately.
Labeling Supplements Awaiting OGD Action
600
< 180 Days
550 > 180 Days

500

450

400

350

300

250

200

150

100

50

0
O D F A J A O D F A J A O D F A J A O D F A J A O D F A J A O D F A J
99 99 00 00 00 00 00 00 01 01 01 01 01 01 02 02 02 02 02 02 03 03 03 03 03 03 04 04 04 04 04 04 05 05 05
ANDA Originals
Percent Approved and Not-Approvable
By Month
100%

90%
Not Approvable
80%

70%

60%

50%

40%

30%

20% Approved

10%

0%
O D F A J A O D F A J A O D F A J A O D F A J A O D F A J A O D F A J
99 99 00 00 00 00 00 00 01 01 01 01 01 01 02 02 02 02 02 02 03 03 03 03 03 03 04 04 04 04 04 04 05 05 05
Median ANDA Review Cycle (Months)
Original Applications & Major Amendments
10

2
Oct Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul
99 00 00 00 00 01 01 01 01 02 02 02 02 03 03 03 03 04 04 04 04 05 05 05
1 - Times correspond to actual applications received. The new ANDA/AADA submission policy that went into effect 1/1/91 allows certain variations in a drug product
to be included in a single application.
2 - In September 1991, the OGD started implementation of the Application Integrity Policy by suspending review of applications suspected of being tainted by fraud.
AIP time has therefore, been subtracted from review time after 9/91. However, before the AIP went into effect, the review of many applications suspected of
containing fraudulent data were suspended. These suspensions were not recorded in the MIS and are reflected in the above chart.
Mean and Median ANDA Review Cycle (Months)
Original Applications & Major Amendments
10

Median Mean
9

2
Oct Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul
99 00 00 00 00 01 01 01 01 02 02 02 02 03 03 03 03 04 04 04 04 05 05 05
1 - Times correspond to actual applications received. The new ANDA/AADA submission policy that went into effect 1/1/91 allows certain variations in a drug product
to be included in a single application.
2 - In September 1991, the OGD started implementation of the Application Integrity Policy by suspending review of applications suspected of being tainted by fraud.
AIP time has therefore, been subtracted from review time after 9/91. However, before the AIP went into effect, the review of many applications suspected of
containing fraudulent data were suspended. These suspensions were not recorded in the MIS and are reflected in the above chart.
Median ANDA CMC Supplement Review Time
Months
10

7
Original/Major Amendments
6

3
Expedited/Minor Amendments
2

0
Oct Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul
99 00 00 00 00 01 01 01 01 02 02 02 02 03 03 03 03 04 04 04 04 05 05 05
1 - Times correspond to actual applications received. The new ANDA/AADA submission policy that went into effect 1/1/91 allows certain variations in a drug product to be
included in a single application.
2 - In September 1991, the OGD started implementation of the Application Integrity Policy by suspending review of applications suspected of being tainted by fraud. AIP
time has therefore, been subtracted from review time after 9/91. However, before the AIP went into effect, the review of many applications suspected of containing
fraudulent data were suspended. These suspensions were not recorded in the MIS and are reflected in the above chart.
3 - Global Supplements are Collapsed
Percent of Original Submissions
Mean
35
with Refuse to Receive Action

30

25

20

15

10

0
Oct Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr
99 00 00 00 00 01 01 01 01 02 02 02 02 03 03 03 03 04 04 04 04 05 05
Status as of June 30, 2005. Percentages for recent months may increase due to future R/R actions
Original ANDAs Pending > 180 Days
150

125

100

75

50

25

0
O D F A J A O D F A J A O D F A J A O D F A J A O D F A J A O D F A J
99 99 00 00 00 00 00 00 01 01 01 01 01 01 02 02 02 02 02 02 03 03 03 03 03 03 04 04 04 04 04 04 05 05 05
ANDAs CMC Supplements Pending > 180 Days
300

250

200

150

100

50

0
O D F A J A O D F A J A O D F A J A O D F A J A O D F A J A O D F A J
99 99 00 00 00 00 00 00 01 01 01 01 01 01 02 02 02 02 02 02 03 03 03 03 03 03 04 04 04 04 04 04 05 05 05
Please note that abrupt changes in the level of pending supplements are the result of global submissions to all applications held by a
single firm. Changes other than these will be explained separately.