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U.S. Department of Health and Human Services

Drugs

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Priority NDA and BLA Approvals in 2002

NDA Number ProprietaryName 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).