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CDER
Priority NDA Approvals in Calendar Year 2002
Updated through December 31, 2002
| NDA Number |
Proprietary
Name |
Established
Name |
Applicant |
Chemical
Type |
Review
Classification |
Approval
Date |
Indication |
|
N021175 |
Atnaa |
Atropine; Pralidoxime Chloride |
U.S. Army |
3 |
P |
17-Jan-02 |
Atnaa provides for the use in an
autoinjector for the treatment of poisoning by susceptible
organophosphorous nerve agents having anticholinesterase
activity. |
|
N021232 |
Orfadin |
Nitisinone |
Swedish Orphan |
1 |
P, O |
18-Jan-02 |
Orfadin provides for the use for
adjunctive therapy to dietary restriction of tyrosine and
phenylalanine in the treatment of hereditary tyrosinemia type 1. |
|
N021272 |
Remodulin |
Treprostinil Sodium |
United Therapeutics |
1 |
P, O |
21-May-02 |
Remodulin is indicated for the
treatment of pulmonary arterial hypertension (PAH). |
|
N021196 |
Xyrem |
Sodium Oxybate |
Orphan Medical |
1 |
P, O |
17-Jul-02 |
Xyrem is indicated for the
treatment of cataplexy associated with narcolepsy. |
|
N021200 |
Zelnorm |
Tegaserod Maleate |
Novartis Pharms |
1 |
P |
24-Jul-02 |
Zelnorm is indicated for the
short-term treatment of women with irritable bowel syndrome
(IBS) whose primary bowel symptom is constipation. |
|
N021492 |
Eloxatin |
Oxaliplatin |
Sanofi-Synthelabo |
1 |
P |
09-Aug-02 |
Eloxatin is indicated in
combination with infusional 5-FU/LV for the treatment of
patients with metastatic carcinoma of the colon or rectum whose
disease has recurred or progressed during or within 6 months of
completion of first line therapy with the combination of bolus
5-FU/LV and irinotecan. |
|
N021449 |
Hepsera |
Adefovir Dipivoxil |
Gilead Sciences |
1 |
P |
20-Sep-02 |
Hepsera is indicated for the
treatment of chronic hepatitis B in adults with evidence of
active viral replication and either evidence of persistent
elevations in serum alanine aminotransferase (ALT)/aspartate
aminotransferase (AST) or histologically active disease. |
|
N020733 |
Suboxone |
Buprenorphine Hydrochloride;
Naloxone Hydrochloride Dihydrate |
Reckitt Benckiser |
4 |
P, O |
08-Oct-02 |
Suboxone is indicated for the
treatment of opioid dependence in patients 16 years of age and
older. |
|
N021498 |
Alinia |
Nitazoxanide |
Romark Labs |
1 |
P |
22-Nov-02 |
Alinia is indicated for the
treatment of diarrhea caused by Cryptosporidium parvum and
Giardia lamblia. |
|
N021511 |
Copegus |
Ribavirin |
Hoffmann-La Roche |
3 |
P |
03-Dec-02 |
Copegus is indicated for the
treatment of chronic hepatitis C virus infection for use in
combination with the approved biologic product Pegasys (peginterferon
alfa-2a). |
|
N021023 |
Restasis |
Cyclosporine |
Allergan |
3 |
P |
23-Dec-02 |
Restasis is indicated to increase
tear production in patients whose tear production is presumed to
be suppressed due to ocular inflammation associated with
keratoconjunctivitis sicca. Increased tear production was not
seen in patients currently taking topical anti-inflammatory
drugs or using punctal plugs. |
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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