Peginterferon and other interferons for hepatitis C - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Peginterferon and other interferons for hepatitis C - [Medication] - Quest Diagnostics Patient Health Library Peginterferon and other interferons for hepatitis C - [Medication] - Quest Diagnostics Patient Health Library antiviral, antiviral...
Press Release - November 15, 2005 This compares with a reported mean (range) elimination half-life of 80 hours (50-140 hours) for Pegasys and 40 hours (22-60 hours) for PEG -Intron. 2b clinical trial to evaluate the efficacy and safety of Albuferon in combination with ribavirin in patients with HCV genotype 1 who...
Press Release - October 25, 2005 The fourth treatment group serves as the active control group and receives weekly 180-mcg doses of subcutaneously administered Pegasys (peginterferon alfa -2a).PEG -Intron. Peginterferon alfa -2b plus...
Human Genome Sciences: Albuferon This compares to a reported mean elimination half-life of 80 hours (50-140 hours) for Pegasys and 40 hours (22-60 hours) for PEG -Intron. peg -interferon-a-2b and ribavirin.
Press Release - May 17, 2005 The results demonstrate that Albuferon (albumin-interferon alpha) exhibits more antiviral activity at clinically achieved serum levels than standard interferon alpha or the modified interferons, Pegasys (peginterferon alfa -2a) and Peg -Intron (peginterferon alfa -2b).
Press Release - June 1, 2005 The fourth treatment group will serve as the active control group and will receive weekly 180-mcg doses of subcutaneously administered Pegasys (peginterferon alfa -2a).PEG -Intron. Peginterferon alfa -2b ...
Biotech Tracker News - FDA Committee Will Review Pegasys - Copegus Combination - - - - BioNews BioWeb Companies Products BioReports - - - - - - Biotech Tracker News - FDA Committee Will Review Pegasys - Copegus Combination- November 13, 2002.peginterferon alfa -2b)/Copegus (ribavirin) combination for...
Press Release - April 13, 2005 FOR IMMEDIATE RELEASE CONTACT: Jerry Parrott Vice President, Corporate Communications 301/315-2777 Kate de Santis Director, Investor Relations 301/251-6003 Click here for more information on Albuferon HUMAN GENOME SCIENCES REPORTS POSITIVE RESULTS OF PHASE 2 CLINICAL TRIAL OF ALBUFERON™ IN TREATMENT-NAIVE PATIENTS WITH CHRONIC HEPATITIS C - Mean reduction in HCV viral load of 3...
Press Release - February 16, 2005 FOR IMMEDIATE RELEASE CONTACT: Jerry Parrott Vice President, Corporate Communications 301/315-2777 Kate de Santis Director, Investor Relations 301/251-6003 HUMAN GENOME SCIENCES COMPLETES ENROLLMENT IN A PHASE 2 CLINICAL TRIAL OF ALBUFERON™ IN TREATMENT-NAIVE PATIENTS WITH CHRONIC HEPATITIS C - Preliminary data demonstrate sufficient antiviral activity to support larger Phase ...
http://www.amarbio.com/AJVR.pdf page 10
Therapeutic Biological Approvals 97 South Street Hopkinton, MA 01748 License 1258 02/05/1999 PEGASYS Peginterferon alfa -2a Treatment of adults with chronic hepatitis C who have compensated liver disease and who have not been previously treated with interferon alfa 103964 / 0 Hoffman-La Roche, Inc 340 Kingsland Street Nutley, NJ 07110-1199 License 0136 10/16/2002 PEGASYS Peginterferon alfa ...
Office of Drug Safety: Patient Labeling and Risk Communitation Food and Drug Administration • Center for Drug Evaluation and Research Office of Drug Safety Search Patient Labeling and Risk Communication FDA-Approved Patient Labeling Patient Package Inserts.- For some prescription medicines, FDA approves special patient materials to instruct patients about the safe use of the product
author: PhillipsJ
Antiviral Drugs Advisory Committee Meetings (None held to date) Previous Years 2003 ---- 2002 --- 2001 ---- 2000 ---- 1999 ---- 1998 --- 1997 ---- 1996 2002 Meetings (link to transcripts and other meeting information) Date: 11/14/2002 Topic:- The committee will discuss biologics license application 125061/0, peginterferon alfa -2a copackaged with ribavirin, new drug application 21-511, Hoffmann-La Roche, Inc.,...
Peginterferon alfa-2b - Product Approval Information - Licensing Action FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Peginterferon alfa -2b Product Approval Information - Licensing Action Proper name: Peginterferon alfa -2b Tradename: PEG -Intron Manufacturer: Schering Corp, Kenilworth, NJ, License #0994 Indication for Use: Treatment of chronic hepatitis C in...
Pharmaceutical Research and Manufacturers of America - Enzon Complete a new search Drug Name (Proprietary name/Generic name) Indications Addressed Click on indication to see all drugs for that indication Company Click a company to see all drugs for that company Development Status Notes PEG -INTRON none / peginterferon -alfa 2b Malignant Melanoma Solid Tumors Enzon Bridgewater, NJ Phase III/Phase I -...
Pharmaceutical Research and Manufacturers of America 6, dependent iron overload, 2 years &olde; r - humanized MAb HER2/neu none / humanized MAb HER2/neu Solid Tumors National Cancer Institute Bethesda, MD Phase I/II (NCI Trial) - IL-12 DNA vaccine none / none Solid Tumors National Cancer Institute Bethesda, MD Phase I NCI Trial - INGN 241 adenoviral-mda7 none / none Solid Tumors Introgen Therapeutics Austin, TX Phase II - interleukin...
Pharmaceutical Research and Manufacturers of America - Malignant Melanoma Complete a new search Drug Name (Proprietary name/Generic name) Indications Addressed Click on indication to see all drugs for that indication Company Click a company to see all drugs for that company Development Status Notes MDX-010 (anti-CTLA4) none / none Malignant Melanoma Prostate Cancer Medarex Princeton, NJ Phase II - PEG -INTRON none / ...
Approved Biotechnology Drugs, 2002 - Short-term topical treatment of moderate to severe dermatoses of the scalp; short-term topical treatment of mild to moderate plaque-type psoriasis of non-scalp regions excluding the face and intertriginous areas - May 2000 Dec 2002 - Oncaspar® (PEG -L-asparaginase) - Enzon, Inc., and Rhone-Poulenc Rorer - Treatment of acute lymphoblastic leukemia in patients who are...
Peginterferon - Product Approval Information - Licensing Action Pelliccione: Your request to supplement your biologics license application for Peginterferon alfa -2b (PEG -Intron) to include combination therapy with Ribavirin, USP (Rebetol), for the treatment of chronic hepatitis C has been approved
Peginterferon alfa-2b - Product Approval Information - Licensing Action We acknowledge your written commitments to provide additional information and to conduct post marketing studies as described in your letters of November 28, 2000, and January 12, 2001, as outlined below: To address the safety and efficacy of Peginterferon alfa -2b in African Americans by submitting the data from a study of 100 previously untreated patients with...
Peginterferon alfa-2b - Product Approval Information - Licensing Action FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Peginterferon alfa -2b Product Approval Information - Licensing Action Proper name: Peginterferon alfa -2b Tradename: PEG -Intron Manufacturer: Schering Corp, Kenilworth, NJ, License #0994 Indication for Use: Combination therapy with Ribavirin,...
Prescription Drug User Fee Act - User Fee Billable Therapeutic Products: Approved Under Section 351 of the PHS Act u/vial MedImmune, Inc License 1252 Synagis Palivizumab 103770/0 6/19/1998 50 mg/vial 100 mg/vial Merck & Co., Inc License 0002 Elspar Asparaginase 101063/0 1/10/1978 10,000 IU/vial Novartis Pharmaceuticals Corp License 1244 Simulect Basiliximab 103764/0 5/12/1998 10 mg/vial 20 mg/vial OMJ Pharmaceuticals, Inc License 1196 Regranex Becaplermin 103691/0 12/16/1997 100 mcg Ortho...
V:\DAVDP\CSO\SINHA\NDA\20-903\Labeling\Approval Letters\Approvle\ t032.doc During clinical studies with REBETOL/ PEG - INTRON, all subjects were instructed to take REBETOL Capsules with foodINTRON A in pediatric patients with chronic hepatitis C between 5 and 16 years of age are summarized in TABLE 2
author: Tanima Sinha
V:\DAVDP\CSO\SINHA\NDA\20-903\Labeling\Approval Letters\Approvle\ t032.doc page 4
author: Tanima Sinha
PEG-Intron (Peginterferon alfa-2b) Package Insert FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER Package Insert PEG -Intron TM (Peginterferon alfa -2b) Powder for Injection, Schering Corporation Table of Contents Description Clinical Pharmacology Clinical Studies Indications and Usage Contraindications Warnings Precautions Adverse Reactions Overdosage Dosage and...
