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U.S. Department of Health and Human Services

Drugs

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Priority NDA and BLA Approvals in 2000

NDA Number ProprietaryName Established Name Applicant Chemical Type Review Classification Approval Date Indication
N021107

Lotronex

Alosetron Hydrochloride

Glaxo Wellcome 1 P 09-Feb-00 Lotronex is indicated for the treatment of irritable bowel syndrome (IBS) in female patients whose predominant bowel symptom is diarrhea.
N021084

Skin Exposure Reduction Paste Against Chemical Warfare Agents

Perfluoropolymethylisopropyl  Ether; Polytetrafluoroethylene

U.S. Army 1, 4 P 17-Feb-00 Provides for the use of SERPACWA only in conjunction with Mission Oriented Protective Posture (MOPP) gear to reduce or delay the absorption of chemical warfare agents through the skin when SERPACWA is applied prior to exposure.
N021114

Betaxon

Levobetaxolol Hydrochloride

Alcon 2 P 23-Feb-00 Betraxon is indicated for lowering intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension.
N021119

Visudyne

Verteporfin

QLT Photo 1 P 12-Apr-00 Visudyne provides for the treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularization.
N021130

Zyvox

Linezolid Pharmacia & Upjohn 1 P 18-Apr-00 Zyvox is indicated for the treatment of adult patients with vancomycin-resistant Enterococcus faecium infections, nosocomial pneumonia, complicated and uncomplicated skin and skin structure infections, and community-acquired pneumonia.
N021131

Zyvox

Linezolid Pharmacia & Upjohn 3 P 18-Apr-00 Zyvox is indicated for the treatment of adult patients with vancomycin-resistant Enterococcus faecium infections, nosocomial pneumonia, complicated and uncomplicated skin and skin structure infections, and community-acquired pneumonia.
N021132

Zyvox

Linezolid

Pharmacia & Upjohn 3 P 18-Apr-00 Zyvox is indicated for the treatment of adult patients with vancomycin-resistant Enterococcus faecium infections, nosocomial pneumonia, complicated and uncomplicated skin and skin structure infections, and community-acquired pneumonia.
N021174

Mylotarg

Gemtuzumab Ozogamicin

Wyeth-Ayerst 1 P, O 17-May-00 Mylotarg  is indicated for the treatment pf patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy.
N021056

Targretin

Bexarotene

Ligand Pharm 3 P, O 28-Jun-00 Targretin gel 1% is indicated for the treatment of cutaneous lesions in patients with CTCL (Stage 1A and 1B) who have refractory or persistent disease after other therapies or who have not tolerated other therapies.
N021078

Malarone; Malarone Pediatric

Atovaquone; Proguanil Hydrochloride

Glaxo Wellcome 4 P 14-Jul-00 Malarone is indicated for the treatment and prevention of plasmodium falciparum malaria.
N021214

Rescula

Unoprostone Isopropyl

Ciba Vision 1 P 03-Aug-00 Rescula is indicated for the lowering of intraocular pressure in patients with open-angel 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.
N020929

Pulmicort Respules

Budesonide

AstraZeneca 3 p 08-Aug-00 Pulmicort Respules is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age.
N021199

Quixin

Levofloxacin

Santen 3 P 18-Aug-00 Quixin is indicated for the treatment of bacterial conjunctivitis.
N021226

Kaletra

Lopinavir; Ritonavir Abbott Labs 1, 4 P 15-Sep-00 Keletra is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infections in adults and pediatric patients age six months and older.
N021251

Kaletra

Lopinavir; Ritonavir

Abbott Labs 3, 4 P 15-Sep-00 Keletra is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infections in adults and pediatric patients age six months and older.
N021248

Trisenox

 

Arsenic Trioxide

 

Cell Therapeutics 1 P, O 25-Sep-00 Trisenox is indicated for induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
N020687

Mifeprex

 

Mifepristone)

 

Population Council 1 P 28-Sep-00 Mifeprex is indicated for the medical termination of intrauterine pregnancy through 49 days’ pregnancy.
N021183

Videx EC

 

Didanosine

 

Bristol-Myers Squibb 3 P 31-Oct-00 Videx EC, in combination with other antiretroviral agents, is indicated for the treatment of HIV-1 infection in adults whose management requires once-daily administration of didanosine or an alternative didanosine formulation.
N021205

Trizivir

Abacavir Sulfate; Lamivudine; Zidovudine

Glaxo Wellcome 3 P 14-Nov-00 Trizivir provides for the use either alone or in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N021246

Tamiflu

Oseltamivir Phosphate

Hoffmann-La Roche 3 P 14-Dec-00 Tamiflu is indicated for the treatment of uncomplicated acute illness due to influenza in patients older than one year of age who have been symptomatic for no longer than 2 days.

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).