AARC Respiratory Abstracts: brought to you by Cardinal Health -- INHALED NITRIC OXIDE: FIVE-YEAR EXPERIENCE WITH A PROTOCOL FOR APPROPRIATE USE -- THE EFFECT OF AN INLINE SUCTION CATHETER ON PRESSURE DELIVERY DURING HIGH FREQUENCY OSCILLATORY VENTILATION (HFOV) -- The role of Spirometry in asthma management in Vietnam -- AN ESTABLISHED ROLE FOR RESPIRATORY THERAPY IN A TERTIARYLABOUR AND DELIVERY UNIT -- EXHALATION VALVE RESISTANCE...
AARC Respiratory Abstracts: brought to you by Cardinal Health -- INHALED NITRIC OXIDE: FIVE-YEAR EXPERIENCE WITH A PROTOCOL FOR APPROPRIATE USE -- THE EFFECT OF AN INLINE SUCTION CATHETER ON PRESSURE DELIVERY DURING HIGH FREQUENCY OSCILLATORY VENTILATION (HFOV) -- The role of Spirometry in asthma management in Vietnam -- AN ESTABLISHED ROLE FOR RESPIRATORY THERAPY IN A TERTIARYLABOUR AND DELIVERY UNIT -- EXHALATION VALVE RESISTANCE...
http://www.fda.gov/cder/orange/appendix_a.txt ACTHAR GEL, CORTICOTROPIN H.R.-50, HYDROCHLOROTHIAZIDE HABITROL, NICOTINE (OTC) HALCION, TRIAZOLAM HALDOL SOLUTAB, HALOPERIDOL HALDOL, HALOPERIDOL HALDOL, HALOPERIDOL DECANOATE HALDOL, HALOPERIDOL LACTATE HALDRONE, PARAMETHASONE ACETATE HALFAN, HALOFANTRINE HYDROCHLORIDE HALOG, HALCINONIDE HALOG-E, HALCINONIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL INTENSOL,...
20845_INOmax.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search INOmax (Nitric Oxide) Company:- INO Therapeutics, Inc., Application No.:- 20-845 Approval Date:-12/23/1999 - Approval Letter(s) - Printed Labeling - Medical Review(s) Part 1 - Part 2 - Part 3 - Part 4 - Part 5 - Chemistry Review(s) - Environmental Assessment -...
author: Paul Stauffer
Report to the Nation: Drug Review Priority new drug approvals: Alitretinoin Amprenavir (2 dosage forms) Aspirin/extended release-dipyridamole Bexarotene Busulfan Caffeine citrate Cytarabine liposome Dalfopristin/quinupristin Epirubicin hydrochloride Ganirelix acetate Ketotifen fumarate Levonorgestrel Nedocromil sodium Nitric oxide Orlistat Oseltamivir phosphate Pemirolast potassium Pioglitazone hydrochloride...
author: OLIVERN
NMEs Approved in CY 1999 NMEs Approved in Calendar Year 1999 NDA Number Generic Name- Trade Name Dosage Form Applicant - --- Classification- Approval Date - - - - - - - 20-863 Cilostazol Pletal Tablet Otsuka Pharm 1S 01-15-1999 20-886 Alitretinoin Panretin Topical Gel Ligand Pharm 1-PV 02-02-1999 20-955 Sodium Ferric Gluconate Complex Ferrlicit Injectable R&D Labs 1P 02-18-1999 21-007 Amprenavir Agenerase...
author: Elaine Abraham
FDA Drug Approvals List May 2001 Pylori eradication to reduce the risk of duodenal ulcer recurrence, maintenance of healed duodenal ulcers, short-term treatment of active benign gastric ulcer, short-term treatment of symptomatic gastroesophageal reflux disease (GERD), short-term treatment of erosive esophagitis, maintenance of healing of erosive esophagitis, and pathological hypersecretory conditions including...
http://www.fda.gov/cder/foi/label/2001/20845s1lbl.pdf INOmax TM (nitric oxide) for inhalation 100 and 800 ppm (parts per million) DESCRIPTION INOmax (nitric oxide gas) is a drug administered by inhalationINOmax (nitric oxide) is available in the following sizes: Size D Portable aluminum cylinders containing 353 liters at STP of nitric oxide gas in 800 ppm concentration in...
http://www.fda.gov/cder/foi/label/2001/20845s1lbl.pdf page 1
NO Labeling Nitric oxide, the active substance in INOmax, is a pulmonary vasodilatorINOmax is a gaseous blend of nitric oxide (0.8%) and nitrogen (99.2%)INOmax Figure 1 Methemoglobin concentrations increased during the first 8 hours of nitric oxide exposure
FDA Drug Approvals List December 1999 Original Application #: 020845 Approval Date: 23-DEC-99 Trade Name: INOMAX Chemical Type: 1 Therapeutic Potential: P Dosage Form: INHALATION Applicant: INO THERAPEUTICS INC Active Ingredient(s): NITRIC OXIDE OTC/RX Status: RX Indication(s): For the treatment of term and near-term (-34 weeks) neonates with hypoxic respiratory failure associated with clinical or...
CDER 1999 Report to the Nation 1999 new molecular entities: Alitretinoin (Panretin) Aminolevulinic acid hydrochloride (Levulan Kerastick) Amprenavir (Agenerase) Bexarotene (Targretin) Cilostazol (Pletal) Dalfopristin/ quinupristin (Synercid) Dexmedetomidine hydrochloride (Precedex) Dofetilide (Tikosyn) Doxercalciferol (Hectorol) Entacapone (Comtan) Epirubicin hydrochloride (Ellence) Exemestane (Aromasin)...
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
CDER 1999 Report to the Nation page 11
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
Introduction - Modular EPARs G-L Authorised Medicinal Products for Human Use - Download a PDF copy of the List of Products. G Glivec INN:Imatinib Mesilate (Rev. 1) Glustin INN:Pioglitazone (Rev. 1) Gonal-F INN:Follitropin alfa (Rev. 4) H ...
http://www.biosis.org/ts/media/cdjournals/gazettenews/2002/CPG_News_0208.pdf week 0208 22 Feb 2002 Bayer’s Ciprofloxacin finally loses its basic patent protection in the UK with the expiry of its Supplementary Protection Certificate on 29th January 2002.
Gazette Highlights News 2002 - Thomson Scientific Thomson.com - - - - - Advanced Search - - - EN : JP : CN : KR -- - - Thomson Scientific : Gazette Weekly Highlights News : Gazette Highlights News 2002 - Gazette Highlights News 2002 Click on a week to view more Week 52: We wish all readers a happy and successful New Year!
Reference Listed Drug Labeling Approved in May 2001 May 1 FLOMAX letter label tamsulosin HCl capsules 20-579 S-007 PREVACID letter label lansoprazole delayed-release capsules 20-406 S-038 May 2 EFFEXOR EFFEXOR XR letter label venlafaxine HCl tablets venlafaxine HCl extended-release capsules 20-151 20-699 S-018 S-016 May 3 BUSPAR letter label buspirone HCl tablets 18-731 S-045 INDERIDE LA 80/50 letter label propranolol HCl/HCTZ...
author: USERNAME
http://www.fda.gov/cder/foi/label/2001/20845s1lbl.pdf page 2
Medicinal Products with a Community Marketing authorisation - Status October 2002 page 30 List Medicinal Products granted a Community Marketing Authorisation under the Centralised Procedure Product a) Brandname b) INN c) Part A/ B Company a) Name b) Origin Therapeutic Area a) ATC b) Indication Presentation a) Form b) Strengths c) Number of Presentations EMEA/ CPMP a) Validation b) Opinion ...
author: EMEA
subject: List
duplicates:http://www.emea.eu.int/pdfs/general/direct/listprod/1640502en.pdf
Medicinal Products with a Community Marketing authorisation, Status-September 2002 page 30 Table Medicinal Products granted a Community Marketing Authorisation under the Centralised Procedure Product a) Brandname b) INN c) Part A/ B Company a) Name b) Origin Therapeutic Area a) ATC b) Indication Presentation a) Form b) Strengths c) Number of Presentations EMEA/ CPMP a) Validation b) Opinion ...
author: EMEA
subject: Table
Annual Report 2001 page 50 Report 48 EMEA Annual Report 2001 Product ° Brand name ° INN ° Part A/ B Marketing authorisation holder European Commission ° Opinion received ° Date of decision ° Notification ° Official Journal EMEA/ CPMP ° Validation ° Opinion ° Active time ° Clock stop Therapeutic area ° ATC code ° Indication ° Foscan °...
author: EMEA
subject: Report
H:\PM Folder\NDA ltrs\20845s001(ap).doc page 1
author: Zelda McDonald
FY 2000 USER FEE PRIORITY APPROVALS FY 2000 USER FEE PRIORITY APPROVALS NDA# - Trade Name (Generic Name) Dosage Form Applicant Date of Approval Class Indication(s) 21-087 Tamiflu (oseltamivir phosphate) Capsules Hoffmann-La Roche 27-Oct-99 1P Tamiflu is indicated as a treatment of influenza A and BINOmax (nitric oxide) Inhalation (Gas) INO Therapeutics 23-Dec-99 1PV INOmax in conjunction...
author: Brenda Harmon
FY 2000 USER FEE NME APPROVALS FY 2000 USER FEE NME APPROVALS - NDA# Trade Name (Generic Name) Dosage Form Applicant Date of Approval Class Indications(s) - 20-931 Tikosyn (dofetilide) Capsules Pfizer 01-Oct-99 1S Tikosyn is indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm
author: Brenda Harmon
CPMP 18-20 September 2001 Plenary meeting - Technical meeting report page 5 Technical meeting report CPMP/ 2358/ 01 5/ 13 ANNEX 2 to CPMP September 2001 MEDICINAL PRODUCTS GRANTED A COMMUNITY MARKETING AUTHORISATION UNDER THE CENTRALISED PROCEDURE SINCE JULY 2001 PRESS RELEASE Brand name Liprolog INN insulin lispro Marketing Authorisation Holder Eli Lilly and Company Ltd ATC code A10AB04 Indication ...
author: CPMP
subject: Technical meeting report
