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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...
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Approved Biotechnology Drugs, 2002
- Acutely decompensated congestive heart failure with shortness of breath at rest or with minimal activity - Aug 2001 Neulasta™ (pegfilgrastim) - Amgen - Reduction of incidence of infection as manifested by febrile neutropenia in non-myeloid cancer patients receiving certain chemotherapies - Jan 2002 Neumega® (oprelvekin) - Wyeth - Prevention of severe chemotherapy-induced...
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Prescription and OTC Drug Product List 8/2001
ACTHAR GEL -D- BC + AVENTIS 40 UNITS/ML N08372 006 FEB 06, 1956 AUG CAHN -D- BC + 80 UNITS/ML N08372 008 FEB 06, 1956 AUG CAHN -A- BC + QUESTCOR PHARMS 40 UNITS/ML N08372 006 FEB 06, 1956 AUG CAHN -A- BC + 80 UNITS/ML N08372 008 FEB 06, 1956 AUG CAHN DELAVIRDINE MESYLATE TABLET; ORAL RESCRIPTOR -D- + AGOURON 100MG N20705 001 APR 04, 1997 AUG CRLD -A- 100MG N20705 001 APR 04, 1997 AUG...
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Prescription and OTC Drug Product List 11/2002
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 325MG;5MG N40478 001 NOV 08, 2002 NOV NEWA -A- AA 500MG;10MG N40473 001 NOV 06, 2002 NOV NEWA -A- AA 500MG;5MG N40477 001 NOV 06, 2002 NOV NEWA AMCINONIDE LOTION; TOPICAL -A- AMCINONIDE -A- AB ALTANA 0.1% N76329 001 NOV 06, 2002 NOV NEWA CYCLOCORT -D- + FUJISAWA...
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Prescription and OTC Drug Product List 9/2002
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST -A- ADEFOVIR DIPIVOXIL -A- TABLET; ORAL -A- HEPSERA -A- + GILEAD 10MG N21449 001 SEP 20, 2002 SEP NEWA ALBUTEROL SULFATE TABLET, EXTENDED RELEASE; ORAL -A- ALBUTEROL SULFATE -A- AB SIDMAK LABS EQ 4MG BASE N76130 002 SEP 26, 2002 SEP NEWA -A- AB EQ 8MG BASE N76130 003 SEP 26, 2002 SEP NEWA VOLMAX -D- BC + MURO EQ 4MG BASE N19604...
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_
BIO Citizen Petition (21 CFR § 10.30) Follow- on Therapeutic Proteins Biotechnology Industry Organization (BIO) 1225 Eye Street, NW, Suite 400 Washington, D
16 iv) Post- Hatch- Waxman Interpretations ...............................
3/ This document includes provisions that are at odds with the statute and long- standing agency interpretations of the FDCA forbidding...
duplicates:
http://www.bio.org/link.asp?url=%2Freg%2FBIO%5FCP%2D%2DFINAL%5FDRAFT%5F4%5F22%5F03%2Epdf
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FDA Drug Approvals List July 2000
- Drug Approvals for July 2000 Definitions and Notes Original New Drug Applications Original Application #: 050779 Approval Date: 27-JUL-00 Trade Name: CEFAZOLIN AND DEXTROSE Chemical Type: 5 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: B BRAUN MEDICAL INC Active Ingredient(s): CEFAZOLIN SODIUM OTC/RX Status: RX Indication(s): For the treatment of respiratory tract...
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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...
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Serono and Amgen Sign License Agreement For Multiple Sclerosis Product
SERONO AND AMGEN SIGN LICENSE AGREEMENT FOR MULTIPLE SCLEROSIS PRODUCT FOR IMMEDIATE RELEASE THOUSAND OAKS, California, USA and GENEVA, SWITZERLAND - November 13, 2002 - Amgen Inc
(virt-x: SEO and NYSE: SRA)
The terms were undisclosed
It has also been approved for certain oncology indications since 1987
Serono is a global biotechnology leader with six recombinant products...
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DOCUMENT INFORMATION PAGE
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 19- 764/ S- 023 Serono, Inc
Joyce: Please refer to your supplemental new drug application dated January 6, 2003, received January 7, 2003, submitted under section 505( b) of the Federal Food, Drug, and Cosmetic Act for Saizen (somatropin [rDNA origin] for...
author: CDER USER
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DOCUMENT INFORMATION PAGE page 1
author: CDER USER
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http://www.phrma.org/publications/publications//2002-10-21.601.pdf page 41
duplicates:
http://www.phrma.org/newmedicines/resources/2002-10-21.93.pdf
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http://www.phrma.org/newmedicines/resources/bio00.pdf page 37
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DDPA April 1996
20-524 BUTENAFINE HCL PENEDERM BUTENAFINE HYDROCHLORIDE 03-APR-96 (CREAM) FOSTER CITY, CA 1% 94404 (ANTIFUNGAL) 20-511 APHTHASOL BLOCK DRUG AMLEXANOX 16-APR-96 (PASTE) JERSEY CITY, NJ 5% 07302 (ANTI-INFLAMMATORY) 19-764 SAIZEN SERONO LABS SOMATROPIN, BIOSYNTHETIC 22-APR-96 (INJECTABLE) NORWELL, MA 5MG/VIAL 02061 10MG/VIAL (HUMAN GROWTH HORMONE) 20-589 CHILDREN'S ADVIL...
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Drug Approvals December 1996
Drug Approvals for December 1996 Definitions and Notes December 1996 Original New Drug Applications Original Application #: 020681 Approval Date: 31-DEC-96 Trade Name: ORTHO TRI-CYCLEN Chemical Type: 6 Therapeutic Potential: S Dosage Form: TABLET Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP Active Ingredient(s): ETHINYL ESTRADIOL; NORGESTIMATE...
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Drug Approvals October 1996
Drug Approvals for October 1996 Definitions and Notes October 1996 Original New Drug Applications Original Application #: 019821 Approval Date: 28-OCT-96 Trade Name: SORIATANE Chemical Type: 2 Therapeutic Potential: S Dosage Form: CAPSULE Applicant: HOFFMAN-LAROCHE Active Ingredient(s): ACITRETIN OTC/RX Status: RX Indication(s): Treatment of severe psoriasis Original Application #:...
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http://www.easy.no/affitech/pdf/das1.pdf page 1
duplicates:
http://www.iscpubs.com/articles/abl/b0002das.pdf
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Alkermes® - News
HOME News Vivitrex® Background Kit 2003 Press Releases 2002 Press Releases 2001 Press Releases 2000 Press Releases 1999 Press Releases 1998 Press Releases 1997 Press Releases Alkermes And Serono To Proceed With Development Of Long-Acting Formulation Of Recombinant Human Follicle Stimulating Hormone(r-hFSH) Wednesday, May 16, 2001 Cambridge, MA , and Geneva, Switzerland --...
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MBC Globe insert 9.26.02
BIOTECHNOLOGY A guide to understanding investments that make a difference WHAT IS BIOTECHNOLOGY
In California, Genentech becomes the first biotechnology company to go public, seeing its stock go from $35 per share to $71.24 by the end of the first day of trading
Fuller Feinstein Kean Healthcare 1953 1961 1969 1973 1974 1975 1978 1979 1980 1982 1984 1985 1988 1989 1990 1991 1993...
author: Chris Connors
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Serono
Serono is one of the world’s top three biotechnology companies, with sales of USD 1.147 billion (2000) and invests more than 20% of its sales in R&D. They currently have over 30 projects that are in ...
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http://www.iscpubs.com/articles/acl/c0106das.pdf
Although some of these products would require a few m o re years of cli nical study before they can be assessed for their marketability, if successful, a market explosion with a potential of dozens of appro v e d d rugs per year, beginning in 2001, could be expected Table 1 continued Year Product name/ approved biochemical identity Company Indications 1996 Humatrope/ HGH Eli Lilly...
author: Grace Lee
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http://www.iscpubs.com/articles/abl/b0006das.pdf
of Name Location founded employees R& D focus/ product pipeline Biomedical companies Actelion AG A l l s c h w i l 1 9 9 7 1 5 TH 3 0 D rugs targeted to endothelium A m gen (Europe) AG L u c e rn e Not know n Not know n S u p p l i e r / d i s t ri butor of A m gen USA'sp r o d u c t s A p o t e ch SA E p a l i n g e s 1 9 9 6 6 Anti- and proapoptosis drug discove ry, agonist/...
author: Grace Lee
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http://www.iscpubs.com/articles/abl/b0002das.pdf
DAS Table 1 List of approved protein therapeutics Year Product name/ approved biochemical identity Company Indications 1982 Humalog/ human insulin Eli Lilly Diabetes Novolin/ human insulin Novo Nordisk Diabetes 1985 Protropin/ HGH Genentech HGHdeficiency 1986 Roferon- A/ interferon alpha- 2a Hoffmann- La Roche Hairy cell leukemia, AIDS- related Kaposi's sarcoma (1988),* chronic...
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Genentech: Products - Product Information - Nutropin
Home Contact Us Site Index Search [ Products -- Nutropin ] Products Home ONCOLOGY Avastin Herceptin Rituxan Tarceva IMMUNOLOGY Raptiva Xolair VASCULAR MEDICINE Activase Cathflo Activase TNKase SPECIALTY BIOTHERAPEUTICS Nutropin Full Prescribing Information Nutropin AQ Nutropin AQ Pen Pulmozyme Full Prescribing Information Nutropin is produced by Genentech using recombinant DNA...
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Genentech: Products - Product Information - Nutropin AQ
Home Contact Us Site Index Search [ Products -- Nutropin AQ ] Products Home ONCOLOGY Avastin Herceptin Rituxan Tarceva IMMUNOLOGY Raptiva Xolair VASCULAR MEDICINE Activase Cathflo Activase< /a> TNKase SPECIALTY BIOTHERAPEUTICS Nutropin Nutropin AQ Full Prescribing Information Nutropin AQ Product Update Nutropin AQ Pen Pulmozyme Full Prescribing Information New Packaging and Device...
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