Contact Us - Prescription Products: Prescription Products: Information for Patients - Patient Assistance Contact Us - Prescription Products: Information for Patients - Patient Assistance For many years, Wyeth Pharmaceuticals has been committed to helping patients in need to receive their medications.
Contact Us - Prescription Products: Information for Healthcare Professionals - Patient Assistance Contact Us - Prescription Products: Information for Healthcare Providers - Patient Assistance For many years, Wyeth Pharmaceuticals has been committed to helping patients in need to receive their medications.
Wyeth: News & Announcements Back to my archive search Start a new archive search 12/04/2001 Wyeth-Ayerst's Antibody-Targeted Chemotherapy Included In Oncology Practice Guidelines MYLOTARG® (gemtuzumab ozogamicin for Injection) is First Targeted Therapy for Leukemia Recognized by National Comprehensive Cancer Network Madison, N.J., December 4, 2001 – Wyeth-Ayerst Laboratories, the pharmaceutical...
Wyeth: Products: Full Pharmaceutical Product List (A-Z) Select either "Prescribing Information" or "Product Information" to find out more about a specific product.
Wyeth: Products: Human Health ---- Please see Important Warnings and Prescribing Information (PDF) Inderal ® LA (propranolol HCl) Long-Acting Capsules ---- Please see Important Warnings and Prescribing Information (PDF) Inderide ® (propranolol hydrochloride [Inderal ® ] and hydrochlorothiazide) ---- Please see Important Warnings and Prescribing Information (PDF) Lo/Ovral ® Tablets (0.3 mg...
Wyeth: Products: Featured Products (by condition) (amiodarone HCl) ---- Prescribing Information Depression and Generalized Anxiety Disorder Effexor XR ® (venlafaxine HCl) Extended-Release Capsules - - - Product Information ---- Prescribing Information ---- Medication Guide Effexor ® (venlafaxine HCl) Tablets ---- Prescribing Information ---- Medication Guide Gastrointestinal Diseases Protonix ® (pantoprazole sodium) - - ...
Wyeth: Products: Featured Products (A-Z) (amiodarone HCl) ---- Prescribing Information Effexor XR ® (venlafaxine HCl) Extended-Release Capsules - - - Product Information ---- Prescribing Information ---- Medication Guide Effexor ® (venlafaxine HCl) Tablets ---- Prescribing Information ---- Medication Guide Enbrel ® (etanercept) - - - Product Information ---- Please see Important Warnings and Prescribing...
Wyeth: Products: All Products (A-Z) ---- Please see Important Warnings and Prescribing Information (PDF) Inderal ® LA (propranolol HCl) Long-Acting Capsules ---- Please see Important Warnings and Prescribing Information (PDF) Inderide ® (propranolol hydrochloride [Inderal ® ] and hydrochlorothiazide) ---- Please see Important Warnings and Prescribing Information (PDF) Lo/Ovral ® Tablets (0.3 mg...
Therapeutic Biological Approvals Box 251 NETHERLANDS License 1178 07/03/1996 Neulasta Pegfilgrastim To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia 125031 / 0 Amgen, Inc One Amgen Center Drive Thousand Oaks, CA 91320-1799 Li...
Pharmaceutical Research and Manufacturers of America - Acute Myelogenous Leukemia (AML) 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 clofarabine none / none Acute Lymphocytic Leukemia (ALL) Acute Myelogenous Leukemia (AML) Solid Tumors Ilex Oncology San...
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...
CBER, Approval letter, Oprelvekin, prevention of severe thrombocytopenia, reduction of the need for platelet transfusions In accordance with approved labeling, your product will bear the tradename Neumega, and will be marketed in single-use vials containing 5 mg of Oprelvekin Oprelvekin to the Center for Biologics Evaluation and Research (CBER) for release by the Director, CBER, under 21 CFR 610.2
Oprelvekin - Product Approval Information - Licensing Action FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Oprelvekin Product Approval Information - Licensing Action Proper name: Oprelvekin Tradename: Neumega Manufacturer: Genetics Institute, Inc, St
Oprelvekin - Product Approval Information - Licensing Action FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Oprelvekin Product Approval Information - Licensing Action Proper name: Oprelvekin Tradename: Neumega Manufacturer: Genetics Institute, Inc, St
Oprelvekin - Product Approval Information - Licensing Action FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Oprelvekin Product Approval Information - Licensing Action Proper name: Oprelvekin Tradename: Neumega Manufacturer: Genetics Institute, Inc, Andover, MA, License #1163 Indication for Use: Prevention of severe thrombocytopenia and the reduction of the need for platelet...
drugname - Product Approval Information - Licensing Action FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Talk Papers Therapeutic Biological Products FDA Approves First Treatment for Genetic Metabolic Disorder Including Hurler Disorder - 4/30/2003 FDA Approves First Treatment for Fabry Disease - 4/24/2003 FDA Statement on Counterfeit Procrit - 3/11/2003 FDA Approves First Biologic Therapy for...
http://www.easy.no/affitech/pdf/das1.pdf page 1
duplicates:http://www.iscpubs.com/articles/abl/b0002das.pdf
Prescription Drug User Fee Act - User Fee Billable Therapeutic Products: Approved Under Section 351 of the PHS Act IU/mL Corixa Corp License 1614 Bexxar Tositumomab and Iodine I-131 Tositumomab 125011/0 6/27/2003 Therapeutic Regimen Cytogen Corp License 1164 ProstaScint Capromab Pendetide 103608/0 10/28/1996 0.5 mg/mL Elan Pharmaceuticals License 1579 MYOBLOC Botulinum Toxin Type B 103846/0 12/8/2000 5,000 IU/mL Eli Lilly & Company License 1611 Xigris Drotrecogin alfa (Activated) 125029/0 11/21...
http://www.fda.gov/cder/foi/label/2002/opregen091802LB.pdf 1 of 14 NEUMEGA ® 1 [nu- meg< a] 2 (oprelvekin) 3 Rx ONLY 4 5 BOXED WARNING 6 Allergic Reactions Including Anaphylaxis Neumega has caused allergic or hypersensitivity reactions, including anaphylaxisOprelvekin, the active ingredient in Neumega, is produced in Escherichia coli (ENeumega is formulated in single- use vials...
http://www.fda.gov/cder/foi/label/2002/opregen091802LB.pdf page 14
http://www.fda.gov/cder/foi/label/2002/opregen091802LB.pdf page 6
http://www.fda.gov/cder/foi/label/2002/opregen091802LB.pdf page 1
Oprelvekin Genetics Inst. approval letter page 1
http://www.phrma.org/newmedicines/resources/2003-05-12.109.pdf page 47
CBER Transfer of Therapeutic Products to CDER Alteplase Activase Genentech, Inc Anakinra Kineret Amgen, Inc Anistreplase Eminase Wulfing Pharma GmbH Arcitumomab CEA-Scan Immunomedics, Inc Asparaginase Elspar Merck & Co., Inc Basiliximab Simulect Novartis Pharmaceuticals Corp Becaplermin Regranex OMJ Pharmaceuticals, Inc Becaplermin Concentrate - Chiron Corp Botulinum Toxin Type A BOTOX BOTOX COSMETIC Allergan, Inc Botulinum...
author: FDA / CBER
