What's New on the FDA Drugs Site
June 4, 2014
- Current Drug Shortages Index (updated)
- Resolved Drug Shortages: Ketorolac Tromethamine Injection
- Resolved Drug Shortages: Mannitol (Osmitrol, Resectisol) Injection
- Drugs@FDA Data Files (updated)
- FDA Adverse Event Reporting System (FAERS): Latest Quarterly Data Files (updated)
New and Generic Drug Approvals
June 3, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Cortenema | hydrocortisone | Enema;Rectal | Ani Pharms | Manufacturing Change or Addition |
| Increlex | mecasermin recombinant | Injectable;Subcutaneous | Ipsen Inc | Labeling Revision |
| K-Tab | potassium chloride | Tablet, Extended Release;Oral | Abbvie | Manufacturing Change or Addition |
| Nithiodote | sodium nitrite; sodium thiosulfate | Solution, Solution;Intravenous, Intravenous | Hope Pharms | Manufacturing Change or Addition |
| Oxycodone Hydrochloride | oxycodone hydrochloride | Tablet;Oral | Amneal Pharms | Approval |
| Potassium Chloride | potassium chloride | Tablet, Extended Release;Oral | Abbvie | Manufacturing Change or Addition |
| Pramipexole Dihydrochloride | pramipexole dihydrochloride | Tablet;Oral | Strides Arcolab Ltd | Approval |
| Prolia | denosumab | Injectable; Subcutaneous | Amgen | Labeling Revision |
| Vistaril | hydroxyzine pamoate | Capsule;Oral | Pfizer | Labeling Revision |
| Vistaril | hydroxyzine pamoate | Suspension;Oral | Pfizer | Labeling Revision |
| Votrient | pazopanib hydrochloride | Tablet;Oral | Glaxosmithkline | Labeling Revision |
| Xgeva | denosumab | Injectable; Subcutaneous | Amgen | Labeling Revision |
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