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...
EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 VALGANCICLOVIR HYDROCHLORIDE ROCHE PALO 21-304 SE1 001 12-Nov-02 12-Sep-03 10.0 Provides for the use of Valcyte (valganciclovir hydrochloride) 450 mg Tablets for the prevention of cytomegalovirus (CMV) disease in kidney, heart, and kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative)
NDA Approvals for Calendar Year 2001 Braun 5 S 21-Feb-01 21-235 Prozac Weekly Fluoxetine Hydrochloride Eli Lilly 3 S 26-Feb-01 21-169 Reminyl Galantamine Hydrobromide Janssen Research 1 S 28-Feb-01 21-082 Tavist Allergy/Sinus/Headache Acetaminophen/Clemastine Fumarate/Pseudoephedrine Hydrochloride Novartis 4 S 01-Mar-01 21-257 Travatan Travoprost Alcon 1 P 16-Mar-01 21-262 Alphagan P Brimonidine Tartrate...
author: Brenda Harmon
FDA Drug Approvals List March 2001 - Drug Approvals for March 2001 Definitions and Notes Original New Drug Applications Original Application #: 021304 Approval Date: 29-MAR-01 Trade Name: VALCYTE Chemical Type: 2 Therapeutic Potential: P Dosage Form: TABLET Applicant: SYNTEX (USA) INC LLC Active Ingredient(s): VALGANCICLOVIR HYDROCHLORIDE OTC/RX Status: RX Indication(s): For the treatment of...
Cytomegalovirus Infection: Viral Infections: Merck Manual Home Edition Search Recent Searches Index Sections A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Accidents and Injuries Blood Disorders Bone, Joint, and Muscle Disorders Brain, Spinal Cord, and Nerve Disorders Cancer Children's Health Issues Digestive Disorders Disorders of Nutrition and Metabolism Drugs Ear, Nose, and Throat Disorders Eye Disorders Fundamentals Heart and Blood Vessel...
http://www.biosis.org/ts/media/cdjournals/gazettenews/2002/CPG_News_0236.pdf week 0236 6 Sept 2002 A Degree of mystery surrounds the Wellcome Foundation's application for an SPC for Roche’s valganciclovir...
Roche Selected Products Therapeutic Area Product Brand Name / Main Indication Indication Anesthesia and sedation Dormicum/Versed midazolam Cancer Furtulon doxifluridine Cancer of the colon Herceptin trastuzumab Breast cancer Kytril granisetron hydrochloride Cancer Mabthera/Rituxan rituximab Non-Hodgkin's lymphoma Roferon-A interferon alfa-2a Cancer Xeloda capecitabine Breast cancer Cardiovascular diseases...
http://www.phrma.org/newmedicines/resources/2003-11-23.120.pdf Triangle Park, NC Mycobutin ® Pharmacia MAC prophylaxis in patients with advanced HIV infection rifabutin Peapack, NJ NebuPent ® Fujisawa Healthcare PCP prophylaxis aerosol Deerfield, IL pentamidine isethionate Neutrexin MedImmune Oncology treatment of moderate- to- severe PCP in immunocompromised trimetrexate Gaithersburg, MD patients, including patients with AIDS, who are...
http://www.phrma.org/newmedicines/resources/2003-11-23.120.pdf page 12
CDER Report to the Nation: 2001 Food and Drug Administration • Center for Drug Evaluation and Research About CDER - Report Search CDER Report to the Nation: 2001 Table of Contents 1 Drug Review Index Mission Highlights New Drug Review Standard new drugs Priority new drugs New molecular entities Standard NMEs Priority NMEs Orphan drug approvals Notable 2001 new drug approvals New or Expanded Use Review...
author: OLIVERN
Valcyte comparable to Cytovene in preventing CMV in transplants - Advanced Search - - Business Web sites Thomson Current --Drugs Thomson Delphion Thomson Derwent Thomson ISI Thomson ISI --ResearchSoft Techstreet Thomson --Wila-Derwent - - Current Drugs : E-Bulletin : Valcyte comparable to Cytovene in preventing CMV in transplants - E-Bulletin Valcyte comparable to Cytovene in preventing CMV in transplants - Simpler Valcyte ...
http://www.phrma.org/newmedicines/resources/2002-12-05.98.pdf Triangle Park, NC Mycobutin ® Pharmacia MAC prophylaxis in patients with advanced HIV infection rifabutin Peapack, NJ NebuPent ® Fujisawa Healthcare PCP prophylaxis aerosol Deerfield, IL pentamidine isethionate Neutrexin MedImmune Oncology treatment of moderate- to- severe PCP in immunocompromised trimetrexate Gaithersburg, MD patients, including patients with AIDS, who are...
http://www.phrma.org/newmedicines/resources/2002-12-05.98.pdf page 13
http://www.fda.gov/cder/foi/label/2001/21304lbl.pdf DESCRIPTION: Valcyte (valganciclovir HCl tablets) contains valganciclovir hydrochloride (valganciclovir HCl), a hydrochloride salt of the L- valyl ester of ganciclovir that exists as a mixture of two diastereomers
http://www.fda.gov/cder/foi/label/2001/21304lbl.pdf page 22
http://www.fda.gov/cder/foi/label/2001/21304lbl.pdf page 21
http://www.fda.gov/cder/foi/label/2001/21304lbl.pdf page 20
http://www.fda.gov/cder/foi/label/2001/21304lbl.pdf page 19
http://www.fda.gov/cder/foi/label/2001/21304lbl.pdf page 18
http://www.fda.gov/cder/foi/label/2001/21304lbl.pdf page 17
http://www.fda.gov/cder/foi/label/2001/21304lbl.pdf page 16
http://www.fda.gov/cder/foi/label/2001/21304lbl.pdf page 15
http://www.fda.gov/cder/foi/label/2001/21304lbl.pdf page 14
http://www.fda.gov/cder/foi/label/2001/21304lbl.pdf page 13
http://www.fda.gov/cder/foi/label/2001/21304lbl.pdf page 12
