What's New on the FDA Drugs Site
February 13, 2014
- Public Workshop: Advancing the Development of Pediatric Therapeutics (ADEPT): Pediatric Bone Health, March 4, 2014, Pooks Hill Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814. Meeting Information
- Current Drug Shortages Index (updated)
- New Drug Shortage: Dexmethylphenidate Hydrochloride (Focalin) Tablet
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
- Orange Book
- Public Notification: Arth-Q Contains Hidden Drug Ingredient
New and Generic Drug Approvals
February 12, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Bacteriostatic Sodium Chloride 0.9% In Plastic Container | sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Chloraprep One-Step | chlorhexidine gluconate; isopropyl alcohol | Sponge;Topical | Carefusion | Manufacturing Change or Addition |
| Chloraprep One-Step Frepp | chlorhexidine gluconate; isopropyl alcohol | Sponge;Topical | Carefusion | Manufacturing Change or Addition |
| Chloraprep With Tint | chlorhexidine gluconate; isopropyl alcohol | Sponge;Topical | Carefusion | Manufacturing Change or Addition |
| Curosurf | poractant alfa | Suspension;Intratracheal | Cornerstone Therap | Manufacturing Change or Addition |
| Fluorescite | fluorescein sodium | Injectable;Intravenous | Alcon Pharms Ltd | Manufacturing Change or Addition |
| Imbruvica | ibrutinib | Capsule;Oral | Pharmacyclics Inc | Approval |
| Isopto Carpine | pilocarpine hydrochloride | Solution;Ophthalmic | Alcon Res | Manufacturing Change or Addition |
| Janumet Xr | metformin hydrochloride; sitagliptin phosphate | Tablet, Extended Release;Oral | Merck Sharp Dohme | Labeling Revision |
| Renacidin | citric acid; gluconolactone; magnesium carbonate | Solution;Irrigation | United Guardian | Manufacturing Change or Addition |
| Simponi Aria | golimumab | Injectable; Injection | Janssen Biotech | Labeling Revision |
| Sodium Chloride 0.9% In Plastic Container | sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Sodium Chloride In Plastic Container | sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Technelite | technetium tc-99m sodium pertechnetate generator | Solution;Injection, Oral | Lantheus Medcl | Labeling Revision |
| Temozolomide | temozolomide | Capsule; Oral | Sun Pharma Global | Approval |
| Timentin | clavulanate potassium; ticarcillin disodium | Injectable;Injection | Glaxosmithkline | Manufacturing Change or Addition |
| Xarelto | rivaroxaban | Tablet; Oral | Janssen Pharms | Labeling Revision |
| Zyrtec-D 12 Hour | cetirizine hydrochloride; pseudoephedrine hydrochloride | Tablet, Extended Release;Oral | Mcneil | Manufacturing Change or Addition |
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