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Ustekinumab / Biologic License Application / Food and Drug Administration / BLA


CDER Therapeutic Biologic Billable List Mmm yy
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Company

Sanofi-Aventis U.S. LLC / Bayer Healthcare Pharmaceuticals Inc. / CDER Billable Biologic Product List Biomarin Pharmaceutical Inc. / mL Alexion Pharmaceuticals Inc. / CDER Billable Biologic Product List Hoffmann-La Roche Inc. / Biogen Idec Inc. / Prometheus Laboratories Inc. / Novartis Pharmaceuticals Corp. / CDER Billable Biologic Product List Ipsen Biopharm Limited / Dyax Corp. / EUSA Pharma (USA) Inc. / Human Genome Sciences Inc / Auxilium Pharmaceuticals Inc. / EMD Serono Inc. / Xgeva Denosumab Amylin Pharmaceuticals LLC / GlaxoSmithKline / Regeneron Pharmaceuticals Inc. / Allergan Inc. / mL Tositumomab Healthpoint Ltd. / MedImmune LLC / mL Glaxo Group Limited / mL Yervoy Ipilimumab BTG International Inc. / mL Genentech Inc. / CDER Billable Biologic Product List EKR Therapeutics Inc. / mL (2mg/mL) Immunex Corp. / CDER Billable Biologic Product List Amgen Inc. / CDER Billable Biologic Product List Genzyme Corp. / CDER Billable Biologic Product List AbbVie Inc. / Janssen Biologics B.V. / mL (50 mg/mL) Raxibacumab Raxibacumab ImClone Systems Inc. / mL Merz Pharmaceuticals / mL Janssen Biotech Inc. / Bristol-Myers Squibb / mL (20 mg/mL) GlaxoSmithKline LLC / /

Event

FDA Phase / /

IndustryTerm

polysorbate solution / billable therapeutic biological products / /

MedicalTreatment

Botox / /

Organization

Center for Drug Evaluation and Research / /

Person

Aria Golimumab / /

Product

Humira / Synagis / Herceptin / Simulect / Rituxan / Aranesp / Neupogen / Activase / Proleukin / Soliris / Neulasta / Remicade / Elitek / Peginterferon / Avastin / Lucentis / Rebif / Betaseron / Avonex / Regranex / Pulmozyme / Aldurazyme / Bexxar / Orencia / Vectibix / Enbrel / Copegus / ReoPro / Ribavirin / Retavase / TNKase / Cathflo Activase / Pegasys / Myozyme / Naglazyme / ProstaScint / Campath / Arcalyst / Erbitux / Xolair / Tysabri / Santyl / Fabrazyme / Botox Cosmetic / Beta-1b / I-131 / Tositumomab / /

Technology

ado / /

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