New and Generic Drug Approvals
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Actiq | fentanyl citrate | Troche/Lozenge;Transmucosal | Cephalon | Manufacturing Change or Addition |
Altoprev | lovastatin | Tablet, Extended Release;Oral | Andrx Labs Llc | Labeling Revision |
Besivance | besifloxacin hydrochloride | Suspension/Drops;Ophthalmic | Bausch and Lomb | Manufacturing Change or Addition |
Cardene | nicardipine hydrochloride | Injectable;Injection | Ekr Therap | Manufacturing Change or Addition |
Cardene In 0.83% Sodium Chloride In Plastic Container | nicardipine hydrochloride | Injectable;Intravenous | Ekr Therap | Manufacturing Change or Addition |
Cardene In 0.86% Sodium Chloride In Plastic Container | nicardipine hydrochloride | Injectable;Intravenous | Ekr Therap | Manufacturing Change or Addition |
Cardene In 4.8% Dextrose In Plastic Container | nicardipine hydrochloride | Injectable;Intravenous | Ekr Therap | Manufacturing Change or Addition |
Cardene In 5.0% Dextrose In Plastic Container | nicardipine hydrochloride | Injectable;Intravenous | Ekr Therap | Manufacturing Change or Addition |
Eliquis | apixaban | Tablet;Oral | Bristol Myers Squibb | Manufacturing Change or Addition |
Ellipta | umeclidinium bromide | Powder;Inhalation | Glaxo Grp Ltd | Approval |
Epi E Z Pen Jr | epinephrine | Injectable;Intramuscular | Mylan Speclt | Labeling Revision |
Epipen | epinephrine | Injectable;Intramuscular, Subcutaneous | Mylan Speclt | Labeling Revision |
Epipen E Z Pen | epinephrine | Injectable;Intramuscular | Mylan Speclt | Labeling Revision |
Epipen Jr. | epinephrine | Injectable;Intramuscular, Subcutaneous | Mylan Speclt | Labeling Revision |
Gilenya | fingolimod | Capsule;Oral | Novartis | Labeling Revision |
Nicoderm Cq | nicotine | Film, Extended Release;Transdermal | Sanofi Aventis Us | Labeling Revision |
Soliris | eculizumab | Injectable; Iv (Infusion) | Alexion Pharm | Efficacy Supplement with Clinical Data to Support |
Soliris | eculizumab | Injectable; Iv (Infusion) | Alexion Pharm | Labeling Revision |
Xenical | orlistat | Capsule;Oral | Hoffmann La Roche | Manufacturing Change or Addition |
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