http://www.fda.gov/cder/orange/appendix_a.txt 4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL HYDROCHLORIDE ULTANE, SEVOFLURANE ULTIVA,...
Drug Index AA ; L-ascorbic acid; Calcium Ascorbate AAP-BHAP ; U-104489; PNU-104489 Abacavir Succinate ; 1592U89 Succinate; Ziagen ® Approved Abacavir & Lamivudine & Zidovudine ; Trizivir® ABC & (-)-3TC & AZT ABT-378 ; Lopinavir; Component of Kaletra; Aluviran® ABT-378 & ABT-538 ; Kaletra ® ; Lopinavir & Ritonavir; Aluviran ® & Norvir ® ABT-538 ; Norvir...
Drug Index AA ; L-ascorbic acid; Calcium Ascorbate AAP-BHAP ; U-104489; PNU-104489 Abacavir Succinate ; 1592U89 Succinate; Ziagen ® Approved Abacavir & Lamivudine & Zidovudine ; Trizivir® ABC & (-)-3TC & AZT ABT-378 ; Lopinavir; Component of Kaletra; Aluviran® ABT-378 & ABT-538 ; Kaletra ® ; Lopinavir & Ritonavir; Aluviran ® & Norvir ® ABT-538 ; Norvir...
20-977_Ziagen Food and Drug Administration • Center for Drug Evaluation and Research Title Search Ziagen (Abacavir Sulfate) Tablets & Oral Solution Company:--Glaxo Wellcome Inc
author: USERNAME
NDAs Approved under Subpart H NDAs Approved under Subpart H NDA # Trade Name Generic -Name Clock Date Approval Date AP Time Approval Basis Indication - - - - - - - - 20199 Hivid Zalcitabine 31-Oct-91 19-Jun-92 7.6 S Combination therapy with zidovudine in advanced HIV infection - - - - - - - - 50698 Biaxin Clarithromycin- 2-Nov-92 23-Dec-93 13.7 S Treatment of disseminated mycobacterial infections due to...
author: Darlene Norris
Fast Track Designated Products Approved since 1998 FAST TRACK DESIGNATED PRODUCTS APPROVED SINCE 1998 Through September 30, 2003 - NDA# NDA Drug Name Sponsor Applicant Approval Date Indication N020972 Sustiva (Efavirenz) 50/ 100/ 200MG Caps Dupont Pharms 9/17/98 Treatment of HIV N20977 Ziagen (Abacavir Sulfate) Tablets Glaxo Wellcome 12/17/98 Treatment of HIV N20978 Ziagen (Abacavir Sulfate) Oral...
author: Michael Lanthier
FDA Drug Approvals List June 2002 - Drug Approvals for June 2002 Definitions and Notes Original New Drug Applications Original Application # 021316 Approval Date: 26-JUN-02 Trade Name: ALTOCOR Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET Applicant: AURA LABORATORIES INC Active Ingredient(s): LOVASTATIN OTC/RX Status: RX INDICATION OF USE: For lowering total cholesterol and LDL-C to target levels as...
FDA Drug Approvals List April 2000 Approvable Original New Drug Applications Original Abbreviated New Drug Applications Original Abbreviated Application # 074657 Approval Date: 28-APR-00 Trade Name: TERAZOSIN HCL Dosage Form: TABLET Applicant: INVAMED INC Active Ingredient(s): TERAZOSIN HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Antibiotic Application# 065041 Approval Date: 28-APR-00 Trade Name: DOXYCYCLINE...
V:\DAVDP\CSO\YOERG\NDA\Crimson\21-205triz\SLRs\slr007\approvall\ tr.doc Abacavir (as TRIZIVIR OR ZIAGEN) SHOULD NOT be restarted following a hypersensitivity reaction to abacavir because more severe symptoms will recur within hours and may include life- threatening hypotension and deathabacavir (as TRIZIVIR or ZIAGEN), and...
author: Virginia Yoerg
V:\DAVDP\CSO\YOERG\NDA\Crimson\21-205triz\SLRs\slr007\approvall\ tr.doc page 2
author: Virginia Yoerg
21-205 S-002 AP TRIZIVIR.pdf In this insert, all dosages for ZIAGEN (abacavir sulfate) are expressed in terms of abacavir abacavir (as TRIZIVIR or ZIAGEN) in patients who have no identified history or unrecognized symptoms of hypersensitivity to abacavir therapy
author: gracej
21-205 S-002 AP TRIZIVIR.pdf page 2
author: gracej
V:\DAVDP\CSO\YOERG\NDA\Crimson\21-205triz\SLRs\cbe003.004\apltr\ .doc Abacavir (as TRIZIVIR OR ZIAGEN) SHOULD NOT be restarted following a hypersensitivity reaction to abacavir because more severe symptoms will recur within hours and may include life- threatening hypotension and deathabacavir (as TRIZIVIR or ZIAGEN) in patients...
author: Virginia Yoerg
V:\DAVDP\CSO\YOERG\NDA\Crimson\21-205triz\SLRs\cbe003.004\apltr\ .doc page 2
author: Virginia Yoerg
V:\DAVDP\CSO\YOERG\NDA\Crimson\21-205triz\SLRs\slr006\approvall\ tr.doc Abacavir (as TRIZIVIR OR ZIAGEN) SHOULD NOT be restarted following a hypersensitivity reaction to abacavir because more severe symptoms will recur within hours and may include life- threatening hypotension and deathabacavir (as TRIZIVIR or ZIAGEN) in patients...
author: Virginia Yoerg
V:\DAVDP\CSO\YOERG\NDA\Crimson\21-205triz\SLRs\slr006\approvall\ tr.doc page 2
author: Virginia Yoerg
Prescription and OTC Drug Product List 12/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 12: December 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - ADD - ABACAVIR SULFATE ALBUTEROL SULFATE - ADD - SOLUTION; ORAL SOLUTION; INHALATION - ADD - ZIAGEN ALBUTEROL SULFATE - ADD - + GLAXO WELLCOME EQ 20MG BASE/ML...
FDA Drug Approvals List December 2000 - Drug Approvals for December 2000 Definitions and Notes Original New Drug Applications Original Application #: 021228 Approval Date: 22-DEC-00 Trade Name: DETROL LA Chemical Type: 3 Therapeutic Potential: S Dosage Form: CAPSULE Applicant: PHARMACIA AND UPJOHN CO Active Ingredient(s): TOLTERODINE TARTRATE OTC/RX Status: RX Indication(s): For the treatment of overactive bladder with...
Hemispherx Biopharma, Inc. -- Research & Development: Clinical Trials: Chronic Fatigue Syndrome (CFS) : AMP 720 Home - | - Corporate Info - | - R & D - | - Products - | - Investor Relations - | - For the Patient - | - Careers at Hemispherx - - Should I Volunteer?Abacavir (Ziagen) 1 6.
Hemispherx Biopharma, Inc. -- For The Patient- Clinical Trials: Chronic Fatigue Syndrome (CFS) : AMP 720 Home - | - Corporate Info - | - R & D - | - Products - | - Investor Relations - | - For the Patient - | - Careers at Hemispherx - - Should I Volunteer?Abacavir (Ziagen) 1 6.
Nucleoside reverse transcriptase inhibitors (NRTIs) for HIV - [Medication] - Quest Diagnostics Patient Health Library Nucleoside reverse transcriptase inhibitors (NRTIs) for HIV Examples Brand Name Chemical Name Ziagen abacavir Videx didanosine, also known as dideoxyinosine, ddI 3TC, Epivir lamivudine Zerit stavudine (d4T) Hivid zalcitabine, also known as dideoxycytidine, ddC Retrovir zidovudine (ZDV), formerly known as azidothymidine (AZT) Trizivir abacavir, zidovudine, and...
Treatment of HIV Disease: The Importance of Drug-Drug Interactions - - - - BioNews BioWeb Companies Products BioReports - - - - - Channels Select Channel -------> Channels Home Page BioWeb Search BioNews Search BioNews Topics BioWatch Tracking BioJob Career Bio/Pharma Events BioNewsCast BioCorporate BioReports Indication/Disease BioZak CD-rom BioTechnologies BioExecutive BioEquities/Stocks BioDrug Discovery BioJournal BioAnalysis BioSuppliers...
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Press Release June 29, 1998 Vertex and Glaxo Wellcome Announce Combination of Investigational Drug Ziagen in Combination with HIV Protease Inhibitors Results in Potent Antiviral Activity, June 29, 1998 Geneva, Switzerland, June 29, 1998 -- Combining the investigational anti-HIV drug Ziagen™ (abacavir) with any one of five HIV protease inhibitors appeared to result in potent suppression of the virus that...
Press Release HIV June30, 1998 Vertex and Glaxo Wellcome Announce Combination of Investigational Drugs Ziagen and Agenerase May be Potent, Durable Against HIV, June 30, 1998 Geneva, Switzerland, June 30, 1998 -- Six of 9 patients with HIV who received a combination of the investigational drugs Ziagen™ (abacavir) and Agenerase™ (amprenavir) had less than 5 viral copies per milliliter of plasma(1) after 48...
Press Release anti-HIV September 21, 1998 Investigational Anti-HIV Drug Agenerase (amprenavir, formerly known as 141W94) to be Made Available Through Early Access Program, September 21, 1998 Cambridge, MA, September 21, 1998 -- The investigational anti-HIV protease inhibitor Agenerase™ (amprenavir, formerly known as 141W94) is now available to patients failing current protease inhibitor containing regimens through a...
