What's New on the FDA Drugs Site
February 2, 2015
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA expands uses of Vyvanse (lisdexamfetamine dimesylate)to treat binge-eating disorder
- FDA’s investigation into patients being injected with simulated IV fluids continues
- National Drug Code Directory
New and Generic Drug Approvals
January 30, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Abreva | docosanol | Cream;Topical | Glaxosmithkline | Labeling Revision |
| Cipro Xr | ciprofloxacin; ciprofloxacin hydrochloride | Tablet, Extended Release;Oral | Bayer Hlthcare | Labeling Revision |
| Depo-Provera | medroxyprogesterone acetate | Injectable;Injection | Pharmacia and Upjohn | Labeling Revision |
| Depo-Subq Provera 104 | medroxyprogesterone acetate | Injectable;Subcutaneous | Pharmacia and Upjohn | Labeling Revision |
| Donepezil Hydrochloride | donepezil hydrochloride | Tablet;Oral | Hetero Labs Ltd V | Approval |
| Eszopiclone | eszopiclone | Tablet;Oral | Macleods Pharms Ltd | Approval |
| Gleevec | imatinib mesylate | Tablet;Oral | Novartis | Efficacy Supplement with Clinical Data to Support |
| Glyxambi | empagliflozin;linagliptin | Tablet; Oral | Boehringer Ingelheim | Approval |
| Memantine Hydrochloride | memantine hydrochloride | Tablet;Oral | Mylan Pharms Inc | Approval |
| Mivacron | mivacurium chloride | Injectable;Injection | Abbvie | Manufacturing Change or Addition |
| Mivacron In Dextrose 5% In Plastic Container | mivacurium chloride | Injectable;Injection | Abbvie | Manufacturing Change or Addition |
| Reclast | zoledronic acid | Injectable;Iv (Infusion) | Novartis | Labeling Revision |
| Vyvanse | lisdexamfetamine dimesylate | Capsule;Oral | Shire Development | Efficacy Supplement with Clinical Data to Support |
| Vyvanse | lisdexamfetamine dimesylate | Capsule;Oral | Shire Development | Labeling Revision |
| Zantac 75 | ranitidine hydrochloride | Tablet;Oral | Boehringer Ingelheim | Labeling Revision |
| Zohydro Er | hydrocodone bitartrate | Capsule, Extended Release;Oral | Zogenix Inc | Manufacturing Change or Addition |
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Wednesday, February 4, 2015
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