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CDER Priority Drug and
Biologic Approvals in Calendar Year 2006
Updated through December 31, 2006
Priority New Drug Application (NDA)
Approvals:
| NDA Number |
Proprietary Name |
Established Name |
Applicant |
Chemical
Type |
Review Classification |
Approval Date |
Indication |
| N021938 |
Sutent |
sunitinib malate |
Pfizer |
1 |
P |
26-Jan-06 |
Provides for the treatment of gastrointestinal stromal
tumor after disease progression on or intolerance to imatinib
mesylate and for the treatment of advanced renal cell
carcinoma. . |
| N021980 |
Fluorescite |
fluorescein |
Alcon Research |
5 |
P |
28-Mar-06 |
Provides for the use in
diagnostic fluoresceine angiography or angioscopy of the
retina and iris vasculature. |
| N021897 |
Vivitrol |
naltrexone |
Alkermes |
3 |
P |
13-Apr-06 |
Provides for the treatment
of alcohol dependence in patients who are able to abstain from
alcohol in an outpatient setting prior to initiation of
treatment with Vivitrol. |
| N021903 |
NeoProfen |
ibuprofen
lysine |
Farmacon-IL,
LLC |
2 |
P, O |
13-Apr-06 |
Provides for the
treatment for closure of a clinically significant patent
ductus arteriosus in premature infants weighing between 500
and 1500 g, who are no more than 32 weeks gestational age when
usual medical management (e.g.., fluid restriction, diuretics,
respiratory support, etc.) is ineffective. |
| N021928 |
Chantix |
varenicline |
Pfizer |
1 |
P |
10-May-06 |
Provides for use as an aid
for smoking cessation. |
N021976 |
Prezista |
darunavir |
Tibotec |
1 |
P |
23-Jun-06 |
When coadministered with 100 mg of
ritonavir, provides for the treatment of human
immunodeficiency virus (HIV) infection in antiretroviral
treatment-experienced adult patients, such as those with HIV-1
strains resistant to more than one protease
inhibitor. |
N021986 |
Sprycel |
dasatinib |
Bristol-Myers
Squibb |
1 |
P, O |
28-Jun-06 |
Provides for the treatment
of adults with chronic myeloid leukemia with resistance or
intolerance to prior therapy including imatinib. |
| N021937 |
Atripla |
efavirenz;
emtricitabine; tenofovir disoproxil fumarate |
Gilead
Sciences |
4 |
P |
12-Jul-06 |
Provides for the treatment
of HIV-1 either alone or in combination with other
antiretroviral agents for the treatment of HIV-1 infection in
adults. |
| N022003 |
Noxafil |
posaconazole |
Schering |
1 |
P |
15-Sep-06 |
Provides for the treatment of prophylaxis of invasive Aspergillus and Candida infections in patients,
13 years of age and older, who are at high risk of developing
these infections due to being severely immunocompromised, such
as hematopoietic stem cell transplant (HSCT) recipients with
Graft versus Host Disease (GVHD) or those with hematologic
malignancies with prolonged neutropenia from
chemotherapy. |
| N021983 |
Duodote |
atropine; pralidoxime
chloride |
Meridian Medical
Technologies |
5 |
P |
28-Sep-06 |
Provides for the treatment
of poisoning by organophosphorous nerve agents as well as
organophosphorous insecticides. |
| N021991 |
Zolinza |
vorinostat |
Merck |
1 |
P,O |
06-Oct-06 |
Provides
for the treatment of cutaneous manifestations in patients with
cutaneous T-cell lymphoma (CTCL) who have progressive,
persistent or recurrent disease on or following two systemic
therapies. |
| N022041 |
Cyanokit |
hydroxocobalamin |
EMD Pharms |
3 |
P,O |
15-Dec-06 |
Provides for the
treatment of known or suspected cyanide poisoning. |
New Drug
Application (NDA) Tentative Approvals under the President's
Emergency Plan for AIDS Relief (PEPFAR):
| NDA Number |
Proprietary Name |
Proper Name |
Applicant |
Chemical Type |
Review Classification |
Approval Date |
Indication |
| N021943 |
efavirenz; lamivudine;
zidovudine |
efavirenz;
lamivudine; zidovudine |
Aurobindo |
4 |
P |
06-Mar-06 |
Provides in combination
with other antiretroviral agents for the treatment of HIV-1
infection. |
| N021939 |
lamivudine; zidovudine;
nevirapine |
lamivudine; zidovudine;
nevirapine |
Aurobindo |
4 |
P |
30-Jun-06 |
Provides in combination
with other antiretroviral agents for the treatment of HIV-1
infection. |
| N021944 |
lamivudine; zidovudine;
abacavir sulfate |
lamivudine;
zidovudine; abacavir sulfate |
Aurobindo |
4 |
P |
30-Jun-06 |
Provides in combination
with other antiretroviral agents for the treatment of HIV-1
infection. |
| N022018 |
lamivudine;
zidovudine; |
lamivudine;
zidovudine; |
Pharmacare |
4 |
P |
28-Aug-06 |
Provides in combination
with other antiretroviral agents for the treatment of HIV-1
infection. |
| N021969 |
lamivudine;
stavudine; nevirapine |
lamivudine;
stavudine; nevirapine |
Cipla Limited |
4 |
P |
17-Nov-06 |
Provides in combination
with other antiretroviral agents for the treatment of HIV-1
infection. |
N021943 is lamivudine 150mg/zidovudine
300mg Fixed-Dose Tablets co-packaged with efavirenz 600mg
Tablets.
N021939 is lamivudine 150mg/zidovudine
300mg/nevirapine 200mg.
N021944 is lamivudine 150mg/zidovudine
300mg co-packaged with abacavir 300mg Tablets.
N022018 is lamivudine 150mg/zidovudine
300mg.
N021969 lamivudine 150mg/stavudine
30mg/nevirapine 200mg and lamivudine 150mg/stavudine
40mg/nevirapine 200mg Tablets
Priority Biologic License Application
(BLA) Approvals:
| BLA Number |
Proprietary Name |
Proper Name |
Applicant |
Review Classification |
Approval Date |
Indication |
125141 |
Myozyme |
alglucosidase alfa |
Genzyme |
P, O |
28-Apr-06 |
Provides for the
treatment of Pompe disease (GAA deficiency). |
125156 |
Lucentis |
ranibizumab |
Genentech |
P |
30-Jun-06 |
Provides for the treatment of patients
with neovascular (wet) age-related macular
degenaration. |
| 125151 |
Elaprase |
idursulfase |
Shire Human Genetic Therapies |
P, O |
24-Jul-06 |
Provides for the treatment of patients
with Hunter syndrome (Mucopolysaccharidosis II, MPS
II). |
| 125147 |
Vectibix |
panitumumab |
Amgen |
P |
27-Sep-06 |
Provides for the
treatment of EGFR-expressing metastatic colorectal carcinoma
with disease progression on or following fluoropyrimidine,
oxaliplatin, and irinotecan containing chemotherapy
regimens. |
NDA Chemical
Type:
1 - New molecular
entity
2 - New ester, new salt, or
other noncovalent derivative
3 - New
formulation
4 - New
combination
5 - New
manufacturer
7 - Drug already
marketed, but without an approved NDA
Review
Classification:
P - Priority Review - Significant improvement compared to marketed products, in the
treatment, diagnosis, or prevention of a disease.
O
- Orphan Designation - Pursuant to Section 526
of the Orphan Drug Act (Public Law 97-414 as amended).
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Last Updated : January 31, 2007 |
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