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CDER
Priority NDA Approvals in Calendar Year 2001
Updated through December 31, 2001
| NDA Number |
Proprietary
Name |
Established
Name |
Applicant |
Chemical
Type |
Review
Classification |
Approval
Date |
Indication |
|
N021252 |
Canasa |
Mesalamine |
Axcan Scandipharm |
5 |
P |
05-Jan-01 |
Canasa is indicated for the
treatment of active ulcerative proctitis. |
|
N021227 |
Cancidas |
Caspofungin Acetate |
Merck Research Labs |
1 |
P |
26-Jan-01 |
Cancidas is indicated for the
treatment of invasive aspergillosis in patients who are
refractory to or intolerant of other therapies. |
|
N021257 |
Travatan |
Travoprost |
Alcon Universal |
1 |
P |
16-Mar-01 |
Travatan is indicated for the
reduction of intraocular pressure in patients with open-angle
glaucoma or ocular hypertension who are intolerant of other
intraocular pressure lowering medications or insufficiently
responsive (failed to achieve target IOP determined after
multiple measurements over time) to another intraocular pressure
lowering medication. |
|
N021275 |
Lumigan |
Bimatoprost |
Allergan |
1 |
P |
16-Mar-01 |
Lumigan is indicated for the
reduction of elevated intraocular pressure in patients with
open-angle glaucoma or ocular hypertension who are intolerant of
other intraocular pressure lowering medications or
insufficiently responsive (failed to achieve target IOP
determined after multiple measurements over time) to another
intraocular pressure lowering medication. |
|
N021304 |
Valcyte |
Valganciclovir Hydrochloride |
Syntex (USA) |
2 |
P |
29-Mar-01 |
Valcyte is indicated for the
treatment of cytomegalovirus(CMV) retinitis in patients with
acquired immunodeficiency syndrome (AIDS). |
|
N021335 |
Gleevec |
Imatinib Mesylate |
Novartis Pharms |
1 |
P, O |
10-May-01 |
Gleevec is indicated for the
treatment of patients with chronic myeloid leukemia (CML) in
blast crisis, accelerated phase, or in chronic phase after
failure of interferon-alpha therapy. |
|
N021223 |
Zometa |
Zoledronic Acid |
Novartis Pharms |
1 |
P |
20-Aug-01 |
Zometa is indicated for the
treatment of hypercalcemia of malignancy. |
|
N021324 |
Entocort EC |
Budesonide |
AstraZeneca |
3 |
P |
02-Oct-01 |
Entocort EC is indicated for the
treatment of mild to moderate active Crohn's Disease involving
the ileum and/or ascending colon. |
|
N021356 |
Viread |
Tenofovir Disoproxil Fumarate |
Gilead Sciences |
1 |
P |
26-Oct-01 |
Viread is indicated to be used in
combination with other antiretroviral agents for the treatment
of HIV-1 infection in adults. |
|
N021345 |
Arixtra |
Fondararinux Sodium |
Fonda BV |
1 |
P |
07-Dec-01 |
Arixtra is indicated for the
following: the prophylaxis of deep vein thrombosis, which may
lead to pulmonary embolism: 1) in patients undergoing hip
fracture surgery; 2) in patients undergoing hip replacement
surgery; 3) in patients undergoing knee replacement surgery. |
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).
To access
approval letters, labels, and review packages, go to
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Date created: March 7, 2005; updated
January 19, 2006
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