CDER New March 25, 2014

FDA (U.S. Food and Drug Administration)

What's New on the FDA Drugs Site

March 24, 2014


New and Generic Drug Approvals

March 22, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Auvi-Q epinephrine Injectable;Intramuscular, Subcutaneous Sanofi Aventis Us Manufacturing Change or Addition

 

March 21, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Adenosine adenosine Injectable;Injection Strides Inc Approval
Ethiodol ethiodized oil Oil;Intralymphatic, Intrauterine Guerbet Labeling Revision
Heparin Sodium heparin sodium Injectable;Injection Fresenius Kabi Usa Labeling Revision
Heparin Sodium heparin sodium Injectable;Injection Fresenius Kabi Usa Labeling Revision
Heparin Sodium In Plastic Container heparin sodium Injectable;Injection Fresenius Kabi Usa Labeling Revision
Heparin Sodium Preservative Free heparin sodium Injectable;Injection Fresenius Kabi Usa Labeling Revision
Otezla apremilast Tablet; Oral Celgene Approval
Striant testosterone Tablet, Extended Release;Buccal Actient Pharms Labeling Revision
Synagis palivizumab Vial Medimmune Labeling Revision
Thyrogen thyrotropin alfa Injectable;Injection Genzyme Efficacy Supplement with Clinical Data to Support
Tussionex Pennkinetic chlorpheniramine polistirex; hydrocodone polistirex Suspension, Extended Release;Oral Ucb Inc Manufacturing Change or Addition
Xolair omalizumab Vial Genentech Efficacy Supplement with Clinical Data to Support
Zecuity sumatriptan succinate System;Iontophoresis Nupathe Labeling Revision

 


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