Paladin - For Investors ANNOUCES TTP APPROVAL FOR ANTIZOL ® - THE ONLY APPROVED PRODUCT FOR THE TREATMENT OF ETHYLENE GLYCOL POISONING (Also in PDF format) November 19, 2000 PALADIN SIGNS CANADIAN MARKETING AND DISTRIBUTION AGREEMENT FOR MUSE (Also in PDF format) ---------------------------------------------------------------------------------- October 30, 2000 PALADIN LABS INC.
Paladin - Corporate Info ANNOUCES TTP APPROVAL FOR ANTIZOL ® - THE ONLY APPROVED PRODUCT FOR THE TREATMENT OF ETHYLENE GLYCOL POISONING (Also in PDF format) November 19, 2000 PALADIN SIGNS CANADIAN MARKETING AND DISTRIBUTION AGREEMENT FOR MUSE (Also in PDF format) ---------------------------------------------------------------------------------- October 30, 2000 PALADIN LABS INC.
http://www.fda.gov/cder/orange/appendix_a.txt 3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
Report to the Nation: Drug Review Food and Drug Administration • Center for Drug Evaluation and Research About CDER - Report Search CDER Report to the Nation: 2000 Table of Contents Drug Review New Drug Review New or Expanded Use Review Over-the-Counter Drug Review Many Americans benefited from last year's timely reviews of new prescription medicines, over-the-counter medicines and their generic equivalents
author: OLIVERN
February 15 June 15, 1999 Paladin Acquires the Distribution Rights for Antizol ® (Fomepizole Injection) from Orphan Medical, IncAntizol ® from Orphan Medical, IncAntizol ®, commonly known as 4-MP (4-methylpyrazole), is a synthetic alcohol dehydrogenase...
AntH PI 8.5x11 12/00.KB Fomepizole is soluble in water and very soluble in ethanol, diethyl ether, and chloroform.Fomepizole has been shown in vitro to block alcohol dehydrogenase enzyme activity in dog, monkey, and human liver.Fomepizole or ethanol, given 3 hours after ethylene glycol ingestion, attenuated the metabolic acidosis and prevented the renal tubular damage associated...
author: Ricky
AntH PI 8.5x11 12/00.KB page 1
author: Ricky
EFFICACY SUPPLEMENTS APPROVED IN CY 2000 EFFICACY SUPPLEMENTS APPROVED IN CY 2000 GENERIC NAME APPLICANT NDA NUMBER RECEIPT DATE APPROVAL DATE SUPP TYPE SUPP NUMBER PRIORITY REVIEW TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION IBUPROFEN WHITEHALL ROBINS 20-812 15-Jun-98 12-Jan-00 SE5 003 N 18.9 Provides for the use of Infants' Advil (ibuprofen oral suspension) Concentrated Oral Drops, 50 mg/1.25 mL for ages 6 months...
Drug Approvals for December 1997 Active Ingredient(s): EMEDASTINE DIFUMARATE OTC/RX Status: RX Indication(s): For the temporary relief of the signs and symptoms of allergic conjunctivitis Original Application #: 020786 Approval Date: 24-DEC-97 Trade Name: ALLEGRA-D Chemical Type: 4 Therapeutic Potential: S Dosage Form: TABLET, EXTENDED RELEASE Applicant: HOECHST MARION ROUSSEL, INC Active Ingredient(s): FEXOFENADINE...
Therapeutic Practices in Recurrent Methanol Abusers in the Calgary Health Region A Retrospective Review n n IV ethanol may reinforce abusive pattern l l Therapy is associated with potentially serious side effects Background l Fomepizole is a newer agent with same mechanism of action as EtOH l Advantages include: l l No CNS depression or hypoglycemia Q12h dosing No need for frequent EtOH levels or monitored bed Safer in pregnancy Does not reward recurrent abusers l l Factors...
author: ITS
Annual Report 2001 page 57 Report EMEA Annual Report 2001 55 Product INN Sponsor European Commission ° Opinion received ° Date of decision EMEA/ COMP ° Validation ° Opinion ° Active time ° Clock stop Indication ° Fomepizole ° Idis Ltd ° 11.04.2001 ° 30.05.2001 ° 15.12.2000 ° 11.01.2001 ° 10.04.2001 ° 90 days ° Treatment of methanol...
author: EMEA
subject: Report
http://www.adis.com/files/newsletters/PT/Ptcov26.pdf 3 Ceftriaxone vs azithromycin in typhoid fever 6 Ceftriaxone vs ciprofloxacin in acute invasive diarrhoea 4 Ciprofloxacin vs ceftriaxone in acute invasive diarrhoea 4 Cisplatin + doxorubicin in hepatoblastoma 4 Citalopram in adolescents with PTSD 6 Clotrimazole/ betamethasone cream not for use in diaper dermatitis 10 Dexamethasone: early administration in neonates 'not indicated' 5...
http://www.adis.com/files/newsletters/PT/Ptcov37.pdf pneumoniae resistance 6 Clozapine or olanzapine: hyperglycaemia in adolescents 4 Corticosteroid use in juvenile rheumatoid arthritis 7 Corticosteroids underused in low- income children with asthma 6 Cyclosporin for focal segmental glomerulosclerosis 10 Drug utilisation: inadequate availability of licensed drugs 6 Epoetin alfa + iron dextran in preterm infants 9 Fentanyl attenuates...
http://www.adis.com/files/newsletters/INP/Icov1316.pdf 18 Manidipine vs amlodipine in hypertension 5 Nicorandil in chronic stable angina pectoris 11 Sodium nitroprusside in endstage heart failure 18 Telmisartan: effective against angiotensin II challenge 19 ICD therapy improves post- MI survival 13 UK guidelines for angina pectoris updated 4 ENDOCRINOLOGY Glimepiride ± metformin in type 2 diabetes mellitus 14 GnRH antagonists...
http://www.adis.com/files/newsletters/INP/Icov1319.pdf pylori eradication therapies: cost- effective in Japan 11 Mebendazole for preschool children in Zanzibar 15 Rubella virus vaccine: use in pregnancy 21 Global poliomyelitis eradication initiative hampered 9 MUSCULOSKELETAL COX- 2 inhibitors: risk of CV events debated 21 DMARDs: long- term benefits less than expected 17 Rheumatoid arthritis: changes in management strategies 10...
http://www.freseniushc.com/product/April_1_2001_Update.pdf April 1 2001 Update Addendum A. Update of Calendar Year 2001 Hospital Outpatient Payment Rates and Coinsurance Amounts Effective April 1, 2001 National Minimum Status Relative Payment Unadjusted Unadjusted APC Group Title Indicator Weight Rate Coinsurance Coinsurance 0001 Photochemotherapy ...
http://www.freseniushc.com/product/April_1_2001_Update.pdf page 10 April 1 2001 Update 1880 Vena cava filter H 1881 Dialysis access system H 1882 AICD, other than sing/ dual H 1883 Adapt/ ext, pacing/ neuro lead H 1885 Cath, translumin angio laser H 1887 Catheter, guiding H 1891 Infusion pump, non- prog, perm H 1892 Intro/ sheath, fixed, peel- away H 1893 Intro/ sheath, ...
Press Release 14th Meeting of the Committee for Orphan Medicinal Products Press Release The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44- 20) 74 18 84 00 Fax (44- 20) 75 23 70 40 E- mail: mail@ emea. eudra. org http:// www. emea. eu. int/ 13 June 2001 COMP/ 243/ 01 PRESS RELEASE 14 ...
author: COMP
subject: Press Release
Press Release 14th Meeting of the Committee for Orphan Medicinal Products page 2 Press Release COMP/ 243/ 01 2/ 2 ANNEX I to COMP June 2001 Press Release Medicinal products Designated as Orphan Medicinal Products on 30 May 2001 Active substance Fomepizole Sponsor IDIS Ltd Orphan Indication Treatment of methanol poisoning Opinion receipt date 11/ 4/ 01 Date of Commission Decision 30/ 5/ 01 Active ...
author: COMP
subject: Press Release
