New Drug Application (NDA) Approvals:
| NDA Number |
Proprietary Name |
Established Name |
Applicant |
Chemical Type |
Review Classification |
Approval Date |
| N022013 |
Olux-E |
clobetasol propionate |
Connetics |
5 |
S |
12-Jan-2007 |
| N022000 |
Lialda |
mesalamine |
Shire |
3 |
S |
16-Jan-2007 |
| N021234 |
Flector |
diclofenac epolamine |
INST Biochem |
2 |
S |
31-Jan-2007 |
| N021777 |
Amrix |
cyclobenzaprine hydrochloride |
ECR Pharms |
3 |
S |
01-Feb-2007 |
| N021887 |
Alli |
orlistat |
GlaxoSmithKline |
8 |
S |
07-Feb-2007 |
| N021977 |
Vyvanse |
lisdexamfetamine dimesylate |
New River |
1 |
S |
23-Feb-2007 |
| N022021 |
Altace |
ramipril |
Cobalt |
3 |
S |
27-Feb-2007 |
| N021985 |
Tekturna |
aliskiren |
Novartis |
1 |
S |
05-Mar-2007 |
| N022059 |
Tykerb |
lapatinib |
GlaxoSmithKline |
1 |
P |
13-Mar-2007 |
| N022044 |
Janumet |
sitagliptin/metformin hydrochloride |
Merck |
4 |
S |
30-Mar-2007 |
| N022055 |
Altabax |
retapamulin |
GlaxoSmithKline |
1 |
S |
12-Apr-2007 |
| N021817 |
Reclast |
zoledronic acid |
Novartis |
3 |
P |
16-Apr-2007 |
| N021905 |
Valtropin |
somatropin |
Parexel |
5 |
S |
19-Apr-2007 |
| N021412 |
Zolpidem Tartrate |
zolpidem tartrate |
Biovail |
3 |
S |
25-Apr-2007* |
| N022051 |
Veramyst |
fluticasone furoate |
GlaxoSmithKline |
2 |
S |
27-Apr-2007 |
| N022007 |
Perforomist |
formoterol fumarate dehydrate |
Dey |
3 |
S |
27-Apr-2007* |
| N050810 |
Azasite |
azithromycin |
InSite Vision |
3 |
S |
27-Apr-2007 |
| N022058 |
Supprelin LA |
histrelin acetate |
Indevus |
5 |
S,O |
03-May-2007 |
| N021829 |
Neupro |
rotigotine |
Schwarz BioSciences |
1 |
S |
09-May-2007 |
| N022047 |
Seroquel XR |
quetiapine fumarate |
AstraZeneca |
3 |
S |
17-May-2007 |
| N022076 |
Locoid |
hydrocortisone butyrate |
Ferndale |
3 |
S |
18-May-2007 |
| N021864 |
Lybrel |
levonorgestrel and ethinyl estradiol |
Wyeth |
5 |
S |
22-May-2007 |
| N022064 |
Xyzal |
levocetirizine dihydrochloride |
UCB |
5 |
S |
25-May-2007 |
| N022088 |
Torisel |
temsirolimus |
Wyeth |
1 |
P,O |
30-May-2007 |
| N022052 |
Zyflo CR |
zileuton |
Critical Therapeutics |
3 |
S |
30-May-2007 |
| N022038 |
Divigel |
estradiol |
Upsher-Smith |
5 |
S |
04-Jun-2007 |
| N021738 |
Extina |
ketoconazole |
Stiefel |
3 |
S |
12-Jun-2007 |
| N022116 |
Lexiva |
fosamprenavir calcium |
GlaxoSmithKline |
3 |
P |
14-Jun-2007 |
| N021875 |
Nuvigil |
armodafinil |
Cephalon |
5 |
S |
15-Jun-2007 |
| N022081 |
Letairis |
ambrisentan |
Gilead |
1 |
P,O |
15-Jun-2007 |
| N021753 |
Differin |
adapalene |
Galderma |
3 |
S |
19-Jun-2007 |
| N021990 |
Exforge |
amlodipine;valsartan |
Novartis |
4 |
S |
20-Jun-2007* |
| N022057 |
Endometrin |
progesterone |
Ferring |
3 |
S |
21-Jun-2007 |
| N022083 |
Exelon |
rivastigmine |
Novartis |
3 |
S |
06-Jul-2007 |
| N021909 |
Allegra |
fexofenadine hydrochloride |
Sanofi Aventis |
3 |
S |
26-Jul-2007 |
| N022070 |
Atralin |
tretinoin |
Coria |
3 |
S |
26-Jul-2007 |
| N022014 |
Evamist |
estradiol |
Vivus |
5 |
S |
27-Jul-2007 |
| N022102 |
CaloMist |
cyanocobalamin |
Fleming |
5 |
S |
27-Jul-2007 |
| N022121 |
Tirosint |
levothyroxine sodium |
Institut Biochimique SA |
3 |
S |
01-Aug-2007 |
| N022103 |
Sanctura |
trospium chloride |
Indevus |
3 |
S |
03-Aug-2007 |
| N022128 |
Selzentry |
maraviroc |
Pfizer |
1 |
P |
06-Aug-2007 |
| N022118 |
Fenofibrate |
fenofibrate |
B & H Consulting |
5 |
S |
10-Aug-2007 |
| N022114 |
Zingo |
lidocaine hydrochloride monohydrate |
Anesiva |
3 |
S |
16-Aug-2007 |
| N022119 |
Ammonia |
Ammonia |
Feinstein |
1 |
S |
23-Aug-2007 |
| N022074 |
Somatuline Depot |
lanreotide |
Biomeasure |
1 |
S,O |
30-Aug-2007 |
| N022066 |
Omniscan |
gadodiamide |
GE Healthcare |
5 |
S |
05-Sep-2007 |
| N022025 |
Totect |
dexrazoxane |
Alba BioPharm |
5 |
P |
06-Sep-2007 |
| N022137 |
Fludarabine Phosphate |
fludarabine phosphate |
Ebewe |
3 |
S |
21-Sep-2007 |
| N022100 |
Azor |
amlodipine;olmesartan medoxomil |
Daiichi Sankyo |
4 |
S |
26-Sep-2007 |
| N022026 |
Amlodipine |
amlodipine |
Synthon |
3 |
S |
27-Sep-2007 |
| N022071 |
Lamisil |
terbinafine hydrochloride |
Novartis |
3 |
S |
28-Sep-2007 |
| N021961 |
Simvastatin |
simvastatin |
Synthon |
3 |
S |
09-Oct-2007 |
| N020981 |
Hycamtin |
topotecan |
GlaxoSmithKline |
3 |
P |
11-Oct-2007 |
| N022106 |
Doribax |
doripenem |
Johnson & Johnson |
1 |
S |
12-Oct-2007 |
| N022145 |
Isentress |
raltegravir potassium |
Merck |
1 |
P |
12-Oct-2007 |
| N022065 |
Ixempra |
ixabepilone |
Bristol-Myers Squibb |
1 |
P |
16-Oct-2007 |
| N022122 |
Voltaren |
diclofenac sodium |
Novartis |
3 |
S |
17-Oct-2007 |
| N022127 |
Renvela |
sevelamer carbonate |
Genzyme |
3 |
S |
19-Oct-2007 |
| N022068 |
Tasigna |
nilotinib |
Novartis |
1 |
S,O |
29-Oct-2007 |
| N021398 |
Combigan |
brimonidine tartrate/timolol maleate |
Allergan |
4 |
S |
30-Oct-2007 |
| N022020 |
Protonix |
pantoprazole sodium |
Wyeth |
3 |
S |
14-Nov-2007 |
| N022155 |
Zyrtec |
certirizine hydrochloride |
Pfizer |
8 |
S |
16-Nov-2007 |
| N022048 |
Triesence |
triamcinolone acetonide |
Alcon |
3 |
P |
29-Nov-2007 |
| N022032 |
omeprazole |
omeprazole |
Lachman Consultant Services |
5 |
S |
04-Dec-2007* |
| N022181 |
Kuvan |
sapropterin dihydrochloride |
BioMarin |
1 |
P,O |
13-Dec-2007 |
| N021742 |
Bystolic |
nebivolol |
Mylan Bertek |
1 |
S |
17-Dec-2007 |
| N021519 |
Luvox |
fluvoxamine maleate |
Solvay |
3 |
S |
20-Dec-2007 |
| N022152 |
Stavzor |
valproic acid |
Banner |
3 |
S |
21-Dec-2007* |
* N021412 Zolpidem Tartrate was tentatively approved on 09/21/2006.
* N022007 Perforomist was tentatively approved on 04/27/2007.
* N022032 Omeprazole was tentatively approved on 06/14/2007.
* N021990 Exforge was tentatively approved on 12/21/2006.
* N022152 Stavzor was tentatively approved on 12/21/2007.
New Drug Application (NDA) Tentative Approvals under the President's Emergency Plan for AIDS Relief (PEPFAR):
| NDA Number |
Proprietary Name |
Established Name |
Applicant |
Chemical Type |
Review Classification |
Approval Date |
| N021974 |
lamivudine;stavudine |
lamivudine;stavudine |
Cipla Limited |
4 |
P |
19-Jan-2007 |
| N021939 |
lamivudine;zidovudine; nevirapine |
lamivudine;zidovudine;nevirapine |
Aurobindo |
4 |
P |
29-Jan-2007 |
| N021971 |
lamivudine;stavudine; nevirapine |
lamivudine;stavudine;nevirapine |
Cipla Limited |
4 |
P |
31-Jan-2007 |
| N021988 |
lamivudine;zidovudine; nevirapine |
lamivudine;zidovudine;nevirapine |
Strides Arcolab Limited |
4 |
P |
02-Mar-2007 |
| N021838 |
stavudine;lamivudine |
stavudine;lamivudine |
Strides Arcolab Limited |
4 |
P |
13-Mar-2007 |
| N021854 |
stavudine;lamivudine; nevirapine |
stavudine;lamivudine;nevirapine |
Strides Arcolab Limited |
4 |
P |
13-Mar-2007 |
| N022096 |
lamivudine;zidovudine; efavirenz |
lamivudine;zidovudine;efavirenz |
Strides Arcolab Limited |
3 |
P |
01-Jun-2007 |
| N022097 |
lamivudine;stavidine; efavirenz |
lamivudine;stavidine;efavirenz |
Strides Arcolab Limited |
3 |
P |
01-Jun-2007 |
| N021972 |
lamivudine;stavudine; nevirapine |
lamivudine;stavudine;nevirapine |
Cipla Limited |
3,4 |
P |
13-Aug-2007 |
| N022085 |
lamivudine;stavudine |
lamivudine;stavudine |
Matrix |
4 |
P |
02-Nov-2007 |
N021974 lamivudine 150mg/stavudine 30mg and lamivudine 150mg/stavudine 40mg Tablets was tentatively approved on 01/19/2007 under PEPFAR.
N021971 lamivudine 150mg/zidovudine 300mg/nevirapine 200mg Tablets was tentatively approved on 01/31/2007 under PEPFAR.
N021988 lamivudine 300mg/zidovudine 150mg/nevirapine 200mg Tablets was tentatively approved on 03/02/2007 under PEPFAR.
N021838 stavudine 40mg/lamivudine 150mg Tablets was tentatively approved on 03/13/2007 under PEPFAR.
N021854 stavudine 40mg/lamivudine 150mg/nevirapine 200mg Tablets was tentatively approved on 03/13/2007 under PEPFAR.
N022096 lamivudine 150mg/zidovudine 300mg/efavirenze 600mg Tablets was tentatively approved on 06/01/2007 under PEPFAR.
N022097 lamivudine 150mg/stavidine 40mg/efavirenze 600mg Tablets was tentatively approved on 06/01/2007 under PEPFAR.
N021972 lamivudine 30mg/stavudine 6mg/nevirapine 50mg Tablets was tentatively approved on 08/13/2007 under PEPFAR.
N022145 Isentress 400 mg Tablets was approved on 10/12/2007 under PEPFAR.
N022085 lamivudine 150mg/stavidine 30mg Tablets was tentatively approved on 11/02/2007 under PEPFAR.
Biologic License Application (BLA) Approvals:
| BLA Number |
Proprietary Name |
Proper Name |
Applicant |
Review Classification |
Approval Date |
| BL125166 |
Soliris |
eculizumab |
Alexion |
P,O |
16-Mar-2007 |
| BL125164 |
Mircera |
methoxy polyethylene glycol-epoetin beta |
Hoffman-La Roche |
S |
14-Nov-2007 |
NDA Chemical Type:
1 - New molecular entity
2 - New ester, new salt, or other noncovalent derivative
3 - New dosage form
4 - New combination
5 - New formulation or new manufacturer
7 - Drug already marketed, but without an approved NDA
8 - OTC switch
Review Classification:
P - Priority Review - Significant improvement compared to marketed products, in the treatment, diagnosis, or prevention of a disease.
S - Standard Review - Products that do not qualify for priority review.
O - Orphan Designation - Pursuant to Section 526 of the Orphan Drug Act (Public Law 97-414 as amended).
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