Chronic hepatitis B and- C: a chronic lack of effective treatment - - - - BioNews BioWeb Companies Products BioReports - - - - - Channels Select Channel -------> Channels Home Page BioWeb Search BioNews Search BioNews Topics BioWatch Tracking BioJob Career Bio/Pharma Events BioNewsCast BioCorporate BioReports Indication/Disease BioZak CD-rom BioTechnologies BioExecutive BioEquities/Stocks BioDrug Discovery BioJournal BioAnalysis BioSuppliers...
Biotech Tracker news - Maxim Continues to Gain Back Lost Ground - - - - BioNews BioWeb Companies Products BioReports - - - - - - Maxim Continues to Gain Back Lost Ground-- October 21, 2002.
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.ribavirin) combination for the...
BioPortfolio Limited Both GSK and Gilead are obvious candidates and in light of similar challenges between HBV/HCV and HIV, Datamonitor expects increased portfolio synergies for the management of chronic viral conditions; 10 Summary 11 Key metrics 12 CHAPTER 2 MARKET SEGMENTATION & DEFINITION 29 Strategic scope and focus 29 Market definition 30 Hepatitis B 30 Disease definition 30 Epidemiology 34...
BioPortfolio Limited 39 Chapter 2 Erythropoietins 44 Summary 44 Class overview 44 Mechanism of action 46 Global sales 46 Analysis of leading products 47 Procrit/Eprex (epoetin alpha) 47 Epogen (epoetin alpha) and Aranesp (darbepoetin alpha) 50 NeoRecormon/Epogin (epoetin beta) 52 Late stage R&D activity 53 Hemolink (hemoglobin raffimer) 54 Chapter 3 Interferons 56 Summary 56 Class overview 57 Mechanism...
Teva Pharmaceutical Industries - News and PR - - Search Tevapharm: - - Press Release Teva and Schering-Plough Enter into License Agreement Covering Schering-Plough’s Ribavirin Patents Jerusalem, Israel, March 26, 2003 - Teva Pharmaceutical Industries Ltd.ribavirin.
Teva Pharmaceutical Industries - News and PR - - Search Tevapharm: - - Press Release Teva Announces District Court Grants Motion for Summary Judgment of Non-Infringement of All Ribapharm Patents Related to Rebetol ® Jerusalem, Israel, July 16, 2003 - Teva Pharmaceutical Industries Ltd.Rebetol ®.Ribavirin is used in combination with Interferon Alpha-2B injection...
Teva Pharmaceutical Industries - News and PR Jerusalem, Israel, and Hawthorne, NY, September 23, 2003, September 23, 2003 Teva Announces Approval of Nefazodone HCl Tablets 50 mg, 100 mg, 150 mg, 200 mg and 250 mg Jerusalem, Israel, September 16, 2003 Teva Announces NDA Submission of Rasagiline as a Treatment for Parkinson's Disease Jerusalem, Israel, September 8, 2003 Teva Announces Approval of Ofloxacin Tablets 200 mg, 300 mg,...
Teva Pharmaceutical Industries - News and PR - - Search Tevapharm: - - Press Release Teva Announces Approval Of Ribavirin Capsules Jerusalem, Israel, October 4, 2004 - Teva Pharmaceutical Industries Ltd.Ribavirin Capsules, 200 mg.Ribavirin Capsules are...
Database P P - investigational drugs, therapies and vaccines # - 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 From this page you may order documents with information covering investigational products To purchase documents on-line click on- -link attached to selected document!- The fee is $15 per document Documents are delivered by e-mail...
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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-2a Expanded Indication for...
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
Paragraph IV Patent Certifications - DRUG NAME DOSAGE FORM STRENGTH RLD Acetaminophen Extended-release Tablets 650 mg Tylenol Acetaminophen/ Aspirin/ Caffeine Tablets 250 mg/250 mg/ 65 mg Excedrin (migraine) Acetaminophen and Tramadol Hydrochloride Tablets 325 mg/ 37.5 mg Ultracet Acyclovir Sodium1 Injection 50 mg/mL, 10 mL and 20 mL vials Zovirax Albuterol Sulfate Oral Syrup 2 mg(base)/ 5 mL Ventolin Albuterol...
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., proposed as...
http://www.fda.gov/cder/orange/appendix_a.txt 4, ACETAMINOPHEN PHENAPHEN-650 W/ CODEINE, ACETAMINOPHEN PHENAZINE, PHENDIMETRAZINE TARTRATE PHENAZINE-35, PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PHENERGAN FORTIS, PROMETHAZINE HYDROCHLORIDE PHENERGAN PLAIN, PROMETHAZINE HYDROCHLORIDE PHENERGAN VC W/ CODEINE, CODEINE PHOSPHATE PHENERGAN VC, PHENYLEPHRINE HYDROCHLORIDE PHENERGAN W/ CODEINE, CODEINE...
Patent and Exclusivity Terms I-391 ABLATION OF HIGH-GRADE DYSPLASIA IN BARRETT'S ESOPHAGUS PATIENTS WHO DO NOT UNDERGO ESOPHAGECTOMY I-392 TX OF PED PATIENTS W/PH+ CHRONIC PHASE CML DISEASE RECUR AFTER STEM CELL TRNSPLT OR RESIST TO INTERFERON ALPHA THERAPY.NO CONTROLLED TRIALS DEMONSTRATING A CLINICAL BENEFIT SUCH AS IMPROVE IN DISEASE RELATED SX OR INCREASED SURVIVAL I-393 CHRONIC BACTERIAL PROSTATITIS I-394...
1998 Warning Letters and Untitled Letters to Pharmaceutical Companies DDMAC 6/25 6/29 Maxipime (Cefepime HCl) for Injection Bristol-Myers Squibb DDMAC 6/29 8/3 Mircette (Desogestrel/Ethinyl Estradiol and Ethinyl Estradiol) Tablets Organon DDMAC 6/1 6/9 Naprelan (Naproxen Sodium) Tablets Wyeth-Ayerst DDMAC 6/8 6/29 Nasacort (Triamcinolone Acetonide) Rhone-Poulenc Rorer DDMAC 6/25 6/29 Nasonex (mometasone furoate monohydrate) nasal spray Schering...
NDA Approvals for Calendar Year 2003 NDA APPROVALS FOR CALENDAR YEAR 2003 Updated through December 31, 2003 NDA NUMBER DRUG NAME GENERIC NAME APPLICANT/ SPONSOR CHEMICAL TYPE THERAPEUTIC CLASS APPROVAL DATE - 21434 Xanax XR Alprazolam Pharmacia and Upjohn FR 3 S 17-Jan-03 21305 Sodium Iodide I-131 Sodium Iodide I-131 DraxImage 3,5 S 24-Jan-03 20414 Pyridostigmine Bromide Pyridostigmine Bromide US Army 3 P 05-Feb-03...
author: Susan Daugherty
Approved Biotechnology Drugs, 2002 Biotechnology Information, Advocacy and Business Support | About Us | BIO Events | BIO Members | Join BIO | Member Services | Links | Home CMS Payment System Prescription Coverage & Reimbursement Food & Agriculture Industrial & Environmental Bioethics & Biomedical Research Intellectual Property Regulatory Policies Tax & Fiscal Policies All Issues & Initiatives Press Releases Company...
Reference Listed Drug Labeling Approved in December 2001 Dec 3 FLUDARA letter label fludarabine phosphate for injection 20-038 S-019 TIMOPTIC-XE letter label timolol maleate ophthalmic solution 20-330 S-015 Dec 4 SERZONE letter label nefazodone hydrochloride tablets 20-152 S-028 Dec 6 DESOXYN letter label methamphetamine HCl tablets 5-378 S-020 Dec 7 DURAMORPH PF letter ---- morphine sulfate injection 18-565 S-009 TIMOPTIC letter label...
author: USERNAME
Reference Listed Drug Labeling Approved in October 2001 20-388 S-010 Oct 3 COZAAR HYZAAR letter label label losartan potassium tablets losartan potassium/HCTZ tablets 20-386 20-387 S-022 S-018 INFUVITE PEDIATRIC letter label multiple vitamins for infusion 21-265 S-001 Oct 4 FIORICET W/ CODEINE letter - codeine/butalbital/APAP/caffeine capsules 20-232 S-012 FIORINAL W/CODEINE letter - codeine/butalbitall/aspirin/caffeine capsules 19-429 S...
author: USERNAME
Reference Listed Drug Labeling Approved in July 2001 Jul 1 ESTROSTEP 21 letter label norethindrone acetate/ethinyl estradiol tablets 20-130 S-007 Jul 2 ACTOS letter - pioglitazone HCl tablets 21-073 S-011 SANDOSTATIN SANDOSTATIN LAR letter - octreotide acetate injection octreotide acetate injectable suspension 19-667 21-008 S-038 S-003 Jul 3 PROTONIX IV letter - pantoprazole sodium for injection 20-988 S-004 Jul 9 NICOTROL letter -...
author: USERNAME
