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).
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