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BIOPHARMA FDA Approvals
- - - - 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...
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Database R
R - 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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Database A
A - 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.
See Mepact (2317) Actilon ™ (CPG 10101) (3205) Actimid ™ (CC-4047, CDC 394) (2463) Actimmune ®* (Imukin®, Interferon...
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Database F
F - 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...
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Therapeutic Biological Approvals
- Chiron Corporation 4560 Horton Street Emeryville, CA 94608 License 1106 12/16/1997 AVONEX Interferon beta-1a Revised Package Insert: Updated information regarding serum neutralizing antibodies 103628 / 5008 Biogen, Inc 14 Cambridge Center Cambridge, MA 02142 License 1204 11/12/2002 Betaseron Interferon beta-1b Revised Package Insert: Revised the Clinical Studies section...
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CBER Approval Letter, Agalsidase beta, Fabrazyme, Genzyme Corp
Agalsidase beta is indicated for use in patients with Fabry disease to reduce globotriaosylceramide (GL-3) deposition in capillary endothelium of the kidney and certain other cell types
Under this authorization, you are approved to manufacture Agalsidase beta bulk drug substance at your facility in ------------------------------------
If postmarketing...
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Agalsidase beta - Product Approval Information - Licensing Action
FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Agalsidase beta Product Approval Information - Licensing Action Proper name: Agalsidase beta Tradename: Fabrazyme Manufacturer: Genzyme Corp, Cambridge, MA , License #1596 Indication for Use: For use in patients with Fabry disease to reduce...
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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...
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CMC - Product Review, Agalsidase beta (Fabrazyme), Genzyme Corp. page 57
author: CBER
subject: dob052903
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CMC - Product Review, Agalsidase beta (Fabrazyme), Genzyme Corp. page 56
author: CBER
subject: dob052903
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CMC - Product Review, Agalsidase beta (Fabrazyme), Genzyme Corp. page 55
author: CBER
subject: dob052903
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CMC - Product Review, Agalsidase beta (Fabrazyme), Genzyme Corp. page 54
author: CBER
subject: dob052903
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CMC - Product Review, Agalsidase beta (Fabrazyme), Genzyme Corp. page 53
author: CBER
subject: dob052903
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CMC - Product Review, Agalsidase beta (Fabrazyme), Genzyme Corp. page 52
author: CBER
subject: dob052903
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CMC - Product Review, Agalsidase beta (Fabrazyme), Genzyme Corp. page 51
author: CBER
subject: dob052903
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CMC - Product Review, Agalsidase beta (Fabrazyme), Genzyme Corp. page 50
author: CBER
subject: dob052903
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CMC - Product Review, Agalsidase beta (Fabrazyme), Genzyme Corp. page 49
author: CBER
subject: dob052903
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CMC - Product Review, Agalsidase beta (Fabrazyme), Genzyme Corp. page 48
author: CBER
subject: dob052903
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CMC - Product Review, Agalsidase beta (Fabrazyme), Genzyme Corp. page 47
author: CBER
subject: dob052903
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CMC - Product Review, Agalsidase beta (Fabrazyme), Genzyme Corp. page 46
author: CBER
subject: dob052903
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CMC - Product Review, Agalsidase beta (Fabrazyme), Genzyme Corp. page 45
author: CBER
subject: dob052903
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CMC - Product Review, Agalsidase beta (Fabrazyme), Genzyme Corp. page 44
author: CBER
subject: dob052903
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CMC - Product Review, Agalsidase beta (Fabrazyme), Genzyme Corp. page 43
author: CBER
subject: dob052903
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CMC - Product Review, Agalsidase beta (Fabrazyme), Genzyme Corp. page 42
author: CBER
subject: dob052903
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CMC - Product Review, Agalsidase beta (Fabrazyme), Genzyme Corp. page 41
author: CBER
subject: dob052903
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