Prostaglandin analogs for glaucoma - [Medication] - Quest Diagnostics Patient Health Library Prostaglandin analogs for glaucoma Examples Brand Name Chemical Name Lumigan bimatoprost Xalatan latanoprost Travatan travoprost How It Works Prostaglandin analogs reduce pressure inside the eye ( intraocular pressure , or IOP) by increasing the removal of fluid ( aqueous humor ) from the eye.
Btech News - D.C. BEAT - The Week's Biotech Related News from Capitol Hill (28/1/02) - - - - BioNews BioWeb Companies Products BioReports - - - - - - Btech News - D.C.
What's new at CDER by Date - U.STravatan (travoprost ophthalmic solution), Alcon Inc
author: Paul Stauffer
http://www.fda.gov/cder/orange/appendix_a.txt 2, BUTABARBITAL SODIUM SARISOL, BUTABARBITAL SODIUM APPENDIX A PRODUCT NAME INDEX SATRIC, METRONIDAZOLE SCABENE, LINDANE SCANDONEST L, LEVONORDEFRIN SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE SCLEROSOL, TALC SCRUBTEAM SURGICAL SPONGEBRUSH, HEXACHLOROPHENE SEASONALE, ETHINYL ESTRADIOL SECOBARBITAL SODIUM, SECOBARBITAL SODIUM SECONAL SODIUM, SECOBARBITAL SODIUM SECREFLO, SECRETIN...
21257_Travatan.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Travatan (Travoprost) Ophthalmic Solution Company:- Alcon Application No.:- 21-257 Approval Date:-3/16/2001 - Approval Letter(s) - Printed Labeling - Medical Review(s)- Part 1 - Part 2 - Part 3 - Chemistry Review(s) - Pharmacology Review(s) Part 1 - Part 2 - Microbiology...
author: Paul Stauffer
CDER Report to the Nation: 2001 New molecular entities Almotriptan malate (Axert) Bimatoprost (Lumigan) Bosentan (Tracleer) Caspofungin acetate (Cancidas) Cefditoren pivoxil (Spectracef) Desloratadine (Clarinex) Drospirenone/ethinyl estradiol (Yasmin) Dutasteride (Dutasteride) Ertapenem sodium (Invanz) Etonogestrel/ethinyl estradiol (NuvaRing) Fondaparinux sodium (Arixtra) Formoterol fumarate (Foradil Aerolizer)...
author: OLIVERN
News Along the Pike, March 2001 Food and Drug Administration • Center for Drug Evaluation and Research About CDER Search CDER News Along the Pike March 2001 Volume 7, Issue 3 Center for Drug Evaluation and Research PDF version for printouts
author: Oliver
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
http://www.fda.gov/cder/foi/label/2001/21257lbl.pdf NDA 21- 257 Page 1 TRAVATANae ae (travoprost ophthalmic solution) 0.004% Sterile DESCRIPTION Travoprost is a synthetic prostaglandin F2a analoguetravoprost is: Travoprost is a clear, colorless to slightly yellow oil that is very soluble in acetonitrile, methanol, octanol, and chloroform
http://www.fda.gov/cder/foi/label/2001/21257lbl.pdf page 6
http://www.fda.gov/cder/foi/label/2001/21257lbl.pdf page 2
C:\Puglisi1\N21257S6-8 & 9AP.doc page 1
author: Michael Puglisi
Travatan Consumer Information Travatan ® Brand Name: Travatan ® Active Ingredient: - travoprost Strength(s): 0.004% Dosage Form(s): - Ophthalmic solution Company Name: -- Alcon Lab oratories Availability: ------- Prescription only *Dated Approved by FDA: - March 16 , 2001 *Approval by FDA does not mean that the drug is available for consumers at this time
Medicinal Products with a Community Marketing authorisation - Status October 2002 page 31 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 31 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
02-002 PhRMA NDA 2001 1/24 NDA FDA Review Foreign Product Company Indication/Use Received Approved Time Availability* Travatan ª Alcon Laboratories reduction of elevated 7/ 7/ 00 3/ 16/ 01 8.3 months USA first travoprost Fort Worth, TX intraocular pressure in marketing ophthalmic patients with open- angle solution glaucoma or ocular (P) hypertension For more information contact: Mary Dulle, ...
author: RL
02-002 PhRMA NDA 2001 1/24 page 11
author: RL
02-002 PhRMA NDA 2001 1/24 page 5
author: RL
Annual Report 2001 page 51 Report EMEA Annual Report 2001 49 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 ° MabCampath ... <...
author: EMEA
subject: Report
CPMP 11-13 December 2001 plenary meeting monthly report page 5 Monthly Report CPMP3926/ 01 5/ 12 ANNEX 2 to CPMP Monthly Report December 2001 MEDICINAL PRODUCTS GRANTED A COMMUNITY MARKETING AUTHORISATION UNDER THE CENTRALISED PROCEDURE SINCE NOVEMBER 2001 CPMP MONTHLY REPORT Brand name Travatan INN travoprost Marketing Authorisation Holder Alcon Laboratories (UK) ...
author: CPMP
subject: Monthly Report
FY 2001 USER FEE PRIORITY APPROVALS - FY 2001 USER FEE PRIORITY APPROVALS AS OF SEPTEMBER 30, 2001 - NDA # TRADE NAME (GENERIC NAME) DOSAGE FORM APPLICANT DATE OF APPROVAL CLASS INDICATION(S) 21-183 Videx EC (didanosine) Capsules Bristol-Myers Squibb -31-Oct-00- - 3P Videx EC, in combination with other antiretroviral agents, is indicated for the treatment of HIV-1 infection in adults whose management requires once...
author: Brenda Harmon
FY 2001 USER FEE NME APPROVALS - FY 2001 USER FEE NME APPROVALS AS OF SEPTEMBER 30, 2001 NDA# Trade Name (Generic Name) Dosage Form Applicant Date of Approval Class Indications(s) - 20-873 Angiomax- (bivalirudin) Injection The Medicines Company 15-Dec-00 - 1S Angiomax is used as an anticoagulant in conjunction with aspirin in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty ...
author: Brenda Harmon
CPMP 24 to 26 July 2001 Plenary meeting - Technical meeting report Technical meeting report 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) 74 18 84 16 E- mail: mail@ emea. eudra. org http:// www. emea. eu. int 31 July 2001 CPMP/ 2358/ 01 rev 1 COMMITTEE ...
author: CPMP
subject: Technical meeting report
CPMP 24 to 26 July 2001 Plenary meeting - Technical meeting report page 1 Technical meeting report 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) 74 18 84 16 E- mail: mail@ emea. eudra. org http:// www. emea. eu. int 31 July 2001 CPMP/ 2358/ 01 rev 1 COMMITTEE ...
author: CPMP
subject: Technical meeting report
CPMP Press Release meeting 24-26 July 2001 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) 74 18 84 16 E- mail: mail@ emea. eudra. org http:// www. emea. eu. int/ London, 27 July 2001 CPMP/ 2341/ 01 PRESS ...
author: CPMP
subject: Press Release
