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U.S. Department of Health and Human Services

Drugs

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Priority NDA and BLA Approvals in 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).