New and Generic Drug Approvals
September 12, 2014
September 12, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Advil Liqui-Gels | ibuprofen | Capsule;Oral | Pfizer | Manufacturing Change or Addition |
| Advil Migraine Liqui-Gels | ibuprofen | Capsule;Oral | Pfizer | Manufacturing Change or Addition |
| Afinitor | everolimus | Tablet;Oral | Novartis | Manufacturing Change or Addition |
| Allegra Allergy | fexofenadine hydrochloride | Tablet;Oral | Sanofi Aventis Us | Labeling Revision |
| Allegra Hives | fexofenadine hydrochloride | Tablet;Oral | Sanofi Aventis Us | Labeling Revision |
| Amlodipine and Valsartan | amlodipine;valsartan | Tablet;Oral | Torrent Pharms Ltd | Tentative Approval |
| An-Sulfur Colloid | technetium tc-99m sulfur colloid kit | Solution;Injection, Oral | Pharmalucence | Manufacturing Change or Addition |
| Children's Allegra Allergy | fexofenadine hydrochloride | Tablet;Oral | Sanofi Aventis Us | Labeling Revision |
| Children's Allegra Hives | fexofenadine hydrochloride | Tablet;Oral | Sanofi Aventis Us | Labeling Revision |
| Clindamycin Phosphate and Benzoyl Peroxide | benzoyl peroxide; clindamycin phosphate | Gel;Topical | Mylan Pharms Inc | Manufacturing Change or Addition |
| Daptomycin | daptomycin | Injectable;Injection | Hospira Inc | Approval |
| Emtricitabine;Tenofovir Disoproxil Fumarate;Nevirapine | emtricitabine;tenofovir disoproxil fumarate;nevirapine | Tablet;Oral | Mylan Labs Ltd | Tentative Approval |
| Forteo | teriparatide recombinant human | Injectable;Subcutaneous | Lilly | Manufacturing Change or Addition |
| Glycine 1.5% In Plastic Container | glycine | Solution;Irrigation | B Braun | Manufacturing Change or Addition |
| Humalog | insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Kwikpen | insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 50/50 | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 50/50 Kwikpen | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 50/50 Pen | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 75/25 | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 75/25 Kwikpen | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 75/25 Pen | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Pen | insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humatrope | somatropin recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humulin 70/30 | insulin recombinant human; insulin susp isophane recombinant human | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humulin 70/30 Pen | insulin recombinant human; insulin susp isophane recombinant human | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humulin N | insulin susp isophane recombinant human | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Mycophenolate Mofetil | mycophenolate mofetil | Capsule;Oral | Roxane | Manufacturing Change or Addition |
| Mycophenolate Mofetil | mycophenolate mofetil | Tablet;Oral | Roxane | Manufacturing Change or Addition |
| Naprelan | naproxen sodium | Tablet, Extended Release;Oral | Almatica Pharma Inc | Manufacturing Change or Addition |
| Pomalyst | pomalidomide | Capsule;Oral | Celgene | Labeling Revision |
| Revlimid | lenalidomide | Capsule;Oral | Celgene | Labeling Revision |
| Thalomid | thalidomide | Capsule;Oral | Celgene | Supplement |
| Vibra-Tabs | doxycycline hyclate | Tablet;Oral | Pfizer | Labeling Revision |
| Vibramycin | doxycycline | For Suspension;Oral | Pfizer | Labeling Revision |
| Vibramycin | doxycycline hyclate | Capsule;Oral | Pfizer | Labeling Revision |
| Vibramycin | doxycycline calcium | Suspension;Oral | Pfizer | Labeling Revision |
| Zoloft | sertraline hydrochloride | Tablet;Oral | Pfizer | Labeling Revision |
| Zoloft | sertraline hydrochloride | Concentrate;Oral | Pfizer | Labeling Revision |
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