FDA Drug Approvals List April 2002
- Drug Approvals for April 2002 Definitions and Notes Original New Drug Applications Original Application #: 021310 Approval Date: 05-APR-02 Trade Name: ALORA Chemical Type: 3 Therapeutic Potential: S Dosage Form: PATCH, CONTROLLED RELEASE Applicant: WATSON LABORATORIES INC Active Ingredient(s): ESTRADIOL OTC/RX Status: RX Indication(s): For the prevention of postmenopausal...
Approved Products_2004.xls
LIST OF APPROVED BIOTECHNOLOBY PRODUCTS (Page 1: product 1- 50) Biotechnology companies have already commercialized a great number of drugs. Pulmonary arterial hypertension Actelion/ Genentech 184 Dec- 01 Clarinex Desloratadine Claritin Isomer Aller gic Rhinitis Sepracor 185 Jan- 02 Eli gard Leuprolid acetate Advanced prostate cancer Atrix Laboratories 186 Jan- 02 Neulasta Pe...
author: Reijer
Approved Products_2004.xls page 4
author: Reijer
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, ...
Efficacy Supplements Approved in Calendar Year 2002 (SE1-SE7 AND SE8s
EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2002 (SE1 -SE7)* and EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2002 (SE8)* - GENERIC NAME APPLICANT NDA NUMBER SUPP TYPE SUPP NUMBER RECEIPT DATE APPROVAL DATE PRIORITY REVIEW- TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION ANASTROZOLE ASTRAZENECA 20-541 SE1 010 5-Mar-02 5-Sep-02 Y 6.0 Provides for the use of ARIMIDEX ...
author: Darlene Norris
All Other Q-Z
Secretin More Details Species cross-reactivity: Porcine. Specificity: Recognizes Secretin C-Terminal: 100%. Immunogen: Porcine secretin -BSA. Specificity:-- Recognizes Secretin C-Terminal: 100%. Immunogen:-- Porcine secretin -BSA.Secretin More Details Species ...
ABRF Electronic Discussion Group Archives viewed: Re: Peptide solubility
Re: Peptide solubility Igor Rodionov (rodionov@fibkh.serpukhov.su) Wed, 2 Dec 1998 15:11:11 +0300 Messages sorted by: [ date ] [ thread ] [ subject ] [ author ] Next message: Susana Linskens: "1000 S deuterium lamp" Previous message: Siv Garrod: "1000S Deut.lamp" Maybe in reply to: Ulf Hellman: "Peptide solubility" Dear Ulf, I am not aware of any solubility predicting software, but I...
BIOPHARMA FDA Approvals
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Bio-Link.org Website -- Biotechnology in the News 2002
-- About Bio-Link --Ed, Org & Companies -- OPTION SELECTED VALUE="">Pick A State Pick A State AK AL AR AZ CA So CA No CO CT DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY -- National/Regional Centers ----- Newsletters -- Biotech News -- Curriculum Clearinghouse -- Bio-Link Publications -- Online Courses...
Repligen Corporation
HOME ~ CONTACT US Message from the CEO Management Directions Corporate Governance SEC Filings Annual Reports Analyst Coverage Events & Presentations FAQ Request Investor Information RG1068 (secretin) RG2077 (CTLA4-Ig) RG2417 (uridine) RG2414 (Protein A) Intellectual Property Commercial Products SecreFlo TM Protein A Recombinant...
Prescription and Over-the-Counter Drug Product List: 11/2003
ACTHAR GEL >D> BC + QUESTCOR PHARMS 80 UNITS/ML N08372 008 NOV CTEC >A> + 80 UNITS/ML N08372 008 NOV CTEC CYTARABINE INJECTABLE; INJECTION >D> CYTARABINE >D> AP + GENSIA SICOR PHARMS 100MG/VIAL N16793 001 NOV DISC >D> AP + 500MG/VIAL N16793 002 NOV DISC >D> AP + 1GM/VIAL N16793 003 DEC 21, 1987 NOV DISC >D> AP + 2GM/VIAL N16793 004 DEC 21, 1987 NOV DISC >A> @ SICOR PHARMS 100MG/VIAL...
Approved Biotechnology Drugs, 2000
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...
Milestones 2003
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...
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...
CDER 2002 Report to the Nation; Drug Review
Food and Drug Administration Center for Drug Evaluation and Research About CDER - Report Search CDER Report to the Nation: 2002 Table of Contents Adobe Acrobat version of this document 1 Drug Review Index Mission Highlights New Drug Review List of priority new drugs List of new molecular entities List of orphan new drugs New Drug Review Statistics Priority new drug statistics...
author: OLIVERN
Prescription and OTC Drug Product List 4/2002
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL ACETAMINOPHEN, BUTALBITAL, CAFFEINE, AND CODEINE PHOSPHATE -A- AB VINTAGE PHARMS 325MG;50MG;40MG;30MG N75929 001 APR 22, 2002 APR NEWA ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE;...
Microsoft Word - Q1PressFY04.doc page 2
author: Laura Whitehouse
Microsoft Word - Q1PressFY04.doc page 1
author: Laura Whitehouse
RepliGen Corporation
- Repligen Added to Russell 2000® Index WALTHAM, MA - July 10, 2003 - Repligen Corporation (Nasdaq: RGEN) announced today that it was added to the Russell 2000® Index of publicly traded companies as of June 30, 2003, when Frank Russell Company reconstituted its family of U.S Russell indexes are used by investment managers for index funds and as benchmarks for both...
Microsoft Word - Q4 03060503.doc page 1
author: Laura Whitehouse
BIO Editors &Reporters 03LIVE page 66
author: Elinor
RepliGen Corporation
- New Study Shows Secretin Reduces Post-ERCP Pancreatitis Data Presented at Digestive Disease Week 2003 "Late Breaking Abstracts" Session WALTHAM, MA - May 22, 2003 - Repligen Corporation (Nasdaq: RGEN) announced today that researchers from Duke University Medical Center reported results from a clinical trial that demonstrated that SecreFlo , secretin for...
RepliGen Corporation
- Repligen and Boston University to Develop Autism Symptom Assessment Tools Cure Autism Now Awards Grants for Autism Psychometrics WALTHAM, MA - May 14, 2003 - Repligen Corporation (Nasdaq: RGEN) announced today the initiation of a clinical research collaboration with Boston University Medical Center to evaluate three approaches to quantifying changes in the symptoms of autism
RepliGen Corporation
- Repligen Plans to Conduct a Phase 2 Clinical Trial of Secretin in Schizophrenia WALTHAM, MA - May 14, 2003 - Repligen Corporation (Nasdaq: RGEN) announced today plans to conduct a clinical trial to evaluate RG1068, synthetic human secretin, in patients with schizophrenia "The observation that secretin improved the social deficits of several patients with...
RepliGen Corporation
- Repligen Conference Call to Update Secretin Product Development Program Wednesday, May 14th, 11 a.m EST, to provide an update on the Company's secretin product development program For those who cannot participate in the live conference call, an archive will be available shortly after the call and may be accessed at www.repligen.com Repligen has a Specialty...