* NDA Chemical Types
1
2
3
4
5
6
7
8
** Review Classification
P
S
O
Meaning
New molecular entity (NME)
New ester, new salt, or other noncovalent derivative
New formulation
New combination
New manufacturer
New indication
Drug already marketed, but without an approved NDA
OTC (over-the-counter) switch
Meaning
Priority review drug: A drug that appears to represent an advance over available therapy
Standard review drug: A drug that appears to have therapeutic qualities similar to those of an already marketed drug
Orphan drug
FDA application # Drug name Active ingredients NDA chemical type
(NDA # 022088) TORISEL TEMSIROLIMUS 1
(NDA # 022059) TYKERB LAPATINIB DITOSYLATE 1
(NDA # 022081) LETAIRIS AMBRISENTAN 1
(NDA # 022128) SELZENTRY MARAVIROC 1
(NDA # 021977) VYVANSE LISDEXAMFETAMINE DIMESYLATE 1
(NDA # 021985) TEKTURNA ALISKIREN HEMIFUMARATE 1
(NDA # 022055) ALTABAX RETAPAMULIN 1
(NDA # 021829) NEUPRO ROTIGOTINE 1
(NDA # 022119) AMMONIA N 13 AMMONIA, N-13 1
(NDA # 022074) SOMATULINE DEPOT LANREOTIDE ACETATE 1
(NDA # 021234) FLECTOR DICLOFENAC EPOLAMINE 2
(NDA # 022051) VERAMYST FLUTICASONE FUROATE 2
(NDA # 021817) RECLAST ZOLEDRONIC ACID 3
(NDA # 022116) LEXIVA FOSAMPRENAVIR CALCIUM 3
(NDA # 022057) ENDOMETRIN PROGESTERONE 3
(NDA # 022000) LIALDA MESALAMINE 3
(NDA # 021777) AMRIX CYCLOBENZAPRINE HYDROCHLORIDE 3
(NDA # 022021) ALTACE RAMIPRIL 3
(NDA # 021412) TOVALT ODT ZOLPIDEM TARTRATE 3
(NDA # 022007) PERFOROMIST FORMOTEROL FUMARATE 3
(NDA # 050810) AZASITE AZITHROMYCIN 3
(NDA # 022007) PERFOROMIST FORMOTEROL FUMARATE 3
(NDA # 022076) LOCOID HYDROCORTISONE BUTYRATE 3
(NDA # 022052) ZYFLO CR ZILEUTON 3
(NDA # 021738) EXTINA KETOCONAZOLE 3
(NDA # 021753) DIFFERIN ADAPALENE 3
(NDA # 022083) EXELON RIVASTIGMINE 3
(NDA # 021909) ALLEGRA FEXOFENADINE HYDROCHLORIDE 3
(NDA # 022070) ATRALIN TRETINOIN 3
(NDA # 022121) TIROSINT LEVOTHYROXINE SODIUM 3
(NDA # 022103) SANCTURA XR TROSPIUM CHLORIDE 3
(NDA # 022114) ZINGO LIDOCAINE HYDROCHLORIDE 3
(NDA # 022026) AMLODIPINE AMLODIPINE 3
(NDA # 022071) LAMISIL TERBINAFINE HYDROCHLORIDE 3
(NDA # 022044) JANUMET 4
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
(NDA # 021990) EXFORGE AMLODIPINE BESYLATE; VALSARTAN 4
(NDA # 022100) AZOR 4
AMLODIPINE; OLMESARTAN MEDOXOMIL
(NDA # 022025) TOTECT DEXRAZOXANE 5
(NDA # 022066) OMNISCAN GADODIAMIDE 5
(NDA # 022013) OLUX E CLOBETASOL PROPIONATE 5
(NDA # 021905) VALTROPIN SOMATROPIN RECOMBINANT 5
(NDA # 021864) LYBREL 5
ETHINYL ESTRADIOL; LEVONORGESTREL
(NDA # 022064) XYZAL LEVOCETIRIZINE DIHYDROCHLORIDE 5
(NDA # 022038) DIVIGEL ESTRADIOL 5
(NDA # 021875) NUVIGIL ARMODAFINIL 5
(NDA # 022014) EVAMIST ESTRADIOL 5
(NDA # 022102) CALOMIST CYANOCOBALAMIN 5
(NDA # 022118) FENOFIBRATE FENOFIBRATE 5
(NDA # 022058) SUPPRELIN LA HISTRELIN ACETATE 5
(NDA # 022138) LOVENOX ENOXAPARIN SODIUM 6
(NDA # 022016) VAPRISOL CONIVAPTAN HYDROCHLORIDE 6
(NDA # 022045) YAZ DROSPIRENONE; ETHINYL ESTRADIOL 6
(NDA # 022043) INVEGA PALIPERIDONE 6
(NDA # 021853) OMACOR OMEGA-3ACID ETHYL ESTERS 6
(NDA # 022080) RECLAST ZOLEDRONIC ACID 6
(NDA # 022042) EVISTA RALOXIFENE HYDROCHLORIDE 6
(NDA # 021887) ALLI ORLISTAT 8
(NDA # 022137) FLUDARABINE PHOSPHATE
FLUDARABINE PHOSPHATE x
(NDA # 021971) x
LAMIVUDINE; ZIDOVUDINE; NEVIRAPINE
LAMIVUDINE; ZIDOVUDINE; NEVIRAPINE
(NDA # 021974) LAMIVUDINE; STAVUDINE
LAMIVUDINE; STAVUDINE x
(NDA # 021939) LAMIVUDINE x
LAMIVUDINE; ZIDOVUDINE; NEVIRAPINE
(NDA # 021988) LAMIVUDINE; ZIDOVUDINE
LAMIVUDINE; ZIDOVUDINE x
(NDA # 021838) STAVUDINE; LAMIVUDINE
STAVUDINE/LAMIVUDINE x
(NDA # 021854) x
STAVUDIINE; LAMIVUDINE W/NEVIRAPINE
STAVUDIINE; LAMIVUDINE W/NEVIRAPINE
(BLA # 125166) SOLIRIS ECULIZUMAB x
(NDA # 022047) SEROQUEL XR QUETIAPINE FUMARATE x
(NDA # 022096) LAMIVUDINE; ZIDOVUDINE; EFAVIRENZx
LAMIVUDINE; ZIDOVUDINE; EFAVIRENZ
(NDA # 022097) STAVUDINE; LAMIVUDINE; EFAVIRENZ x
STAVUDINE; LAMIVUDINE; EFAVIRENZ
(NDA # 022032) OMEPRAZOLE OMEPRAZOLE x
(NDA # 021972) LAMIVUDINE; STAVUDINE; NEVIRAPINEx
LAMIVUDINE; STAVUDINE; NEVIRAPINE
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
Review classification Company Approval date Month Count * NDA Chemical Types
P WYETH PHARMS INC 5/30/2007 5 10 1
P SMITHKLINE BEECHAM03/13/2007 3 2 2
P GILEAD 06/15/2007 6 22 3
P PFIZER 08/06/2007 8 3 4
S NEW RIVER PHARMS 02/23/2007 2 12 5
S NOVARTIS 03/05/2007 3 7 6
S GLAXO GRP LTD 04/12/2007 4 0 7
S SCHWARZ BIOSCIENCES
05/09/2007 5 1 8
S FEINSTEIN 08/23/2007 8 13 x
S, O BEAUFOUR IPSEN 8/30/2007 8 70 Total
S INST BIOCHEM 01/31/2007 1
S GLAXOSMITHKLINE 04/27/2007 4
P NOVARTIS 04/16/2007 4 8 P
P GLAXO 06/14/2007 6 47 S
S FERRING 6/21/2007 6 0 O
S SHIRE 01/16/2007 1 3 S, O
S ECR 02/01/2007 2 12 x
S KING PHARMS 25
02/27/2007 2 70 Total
S BIOVAIL LABS INTL 04/25/2007 4
S DEY LP 04/27/2007 4 20
S INSPIRE 04/27/2007 4
S DEY LP 05/11/2007 5 15
S FERNDALE LABS 05/18/2007 5
S CRITICAL 05/30/2007 5
10
S STIEFEL LABS INC 06/12/2007 6
S GALDERMA LABS LP 06/19/2007 6
S NOVARTIS 07/06/2007 7 5
S SANOFI AVENTIS US 07/26/2007 7
S CORIA 07/26/2007 7 0
S INST BIOCHIMIQUE 08/01/2007 8
S INDEVUS 08/03/2007 8
S ANESIVA 08/16/2007 8
S SYNTHON PHARMS 09/27/2007 9
S NOVARTIS PHARMS 09/28/2007 8
S MERCK 3/30/2007 3
S NOVARTIS 06/20/2007 6
S DAIICHI SANKYO 09/26/2007 9
P TOPOTARGET 09/06/2007 9
S GE HEALTHCARE 09/05/2007 9
S CONNETICS 01/12/2007 1
S LG LIFE 04/19/2007 4
S WYETH PHARMS INC 05/22/2007 5
S UCB INC 05/25/2007 5
S UPSHER SMITH 06/04/2007 6
S CEPHALON 06/15/2007 6
S KV PHARM 07/27/2007 7
S FLEMING 07/27/2007 7
S LIFECYCLE PHARMA AS
08/10/2007 8
S, O INDEVUS 05/03/2007 5
P SANOFI AVENTIS US 05/16/2007 5
S ASTELLAS 2/28/2007 2
S BERLEX 01/26/2007 1
S JANSSEN LP 04/27/2007 4
S RELIANT PHARMS 06/12/2007 6
S NOVARTIS PHARMS 08/17/2007 8
S, O LILLY 09/13/2007 9
S GLAXOSMITHKLINE CONS
02/07/2007 2
S EBEWE PHARMA 09/21/2007 9
x CIPLA LIMITED 1/31/2007 1
x CIPLA LIMITED 01/19/2007 1
x LTD
AUROBINDO PHARMA01/29/2007 1
x STRIDES ACROLAB 03/02/2007 3
x STRIDES ACROLAB 03/13/2007 3
x STRIDES ACROLAB 03/13/2007 3
x ALEXION PHARM 03/16/2007 3
x ASTRAZENECA 05/17/2007 5
x STRIDES ACROLAB 06/01/2007 6
x STRIDES ACROLAB 06/01/2007 6
x DEXCEL LTD 06/14/2007 6
x CIPLA LIMITED 08/13/2007 8
NDA approvals (2007: 9 months) NMEs 2007 (9 months) No. Status
NME 10 GSK 2 General pharma
New ester, salt, or other derivative 2 Pfizer 1 General pharma
New formulation 22 Novartis 1 General pharma
New combination 3 Wyeth 1 General pharma
New manufacturer 12 Gilead 1 Specialty (US)
New indication 7 New River 1 Specialty (US)
Already marketed w/o approved NDA0 Schwarz 1 Specialty (US)
OTC switch 1 Beaufour Ipsen 1 Specialty (France)
No code 13 Feinstein Institute 1 Academic (US)
Meaning
NDA approvals (2007: 9 months)
Priority review 8
Standard review 47
Orphan drug 0 NDA approvals (2007: 9 months)
Standard & orphan 3
No code 12
25
22
Count
20 to September 30, 2007: 9 months
15 NDA approvals (2007: 9 months)
13
12
10
10 50 47 7
5 45
3
2
1
40 0
0
35
30
25
20
15
10 8
5
0
0
Priority review Standard review Orphan drug Standard &
orphan
months)
12
3
Standard & No code
orphan
Company
ALEXION PHARM
ANESIVA
ASTELLAS
ASTRAZENECA
AUROBINDO PHARMA LTD
BEAUFOUR IPSEN
BERLEX
BIOVAIL LABS INTL
CEPHALON
CIPLA LIMITED
CIPLA LIMITED
CIPLA LIMITED
CONNETICS
CORIA
CRITICAL
DAIICHI SANKYO
DEXCEL LTD
DEY LP
DEY LP
EBEWE PHARMA
ECR
FEINSTEIN
FERNDALE LABS
FERRING
FLEMING
GALDERMA LABS LP
GE HEALTHCARE
GILEAD
GLAXO
GLAXO GRP LTD
GLAXOSMITHKLINE
GLAXOSMITHKLINE CONS
INDEVUS
INDEVUS
INSPIRE
INST BIOCHEM
INST BIOCHIMIQUE
JANSSEN LP
KING PHARMS
KV PHARM
LG LIFE
LIFECYCLE PHARMA AS
LILLY
MERCK
NEW RIVER PHARMS
NOVARTIS
NOVARTIS
NOVARTIS
NOVARTIS
NOVARTIS PHARMS
NOVARTIS PHARMS
PFIZER
RELIANT PHARMS
SANOFI AVENTIS US
SANOFI AVENTIS US
SCHWARZ BIOSCIENCES
SHIRE
SMITHKLINE BEECHAM
STIEFEL LABS INC
STRIDES ACROLAB
STRIDES ACROLAB
STRIDES ACROLAB
STRIDES ACROLAB
STRIDES ACROLAB
SYNTHON PHARMS
TOPOTARGET
UCB INC
UPSHER SMITH
WYETH PHARMS INC
WYETH PHARMS INC