What's New on the FDA Drugs Site
July 23, 2014
- FDA approves Targiniq ER with abuse-deterrent properties
- Bioequivalence Recommendations for Specific Products (updated)
- Drugs@FDA Data Files (updated)
- FDA approves Zydelig (idelalisib) for three types of blood cancers
- FDA Drug Shortages: New and Updated
- Bupivacaine Hydrochloride (Marcaine, Sensorcaine) Injection (Currently in Shortage)
- Cefazolin Injection (Currently in Shortage)
- Clindamycin Phosphate (Cleocin) Injection (Currently in Shortage)
- Copper Injection (Currently in Shortage)
- Dextrose 5% Injection Bags (Currently in Shortage)
- Epinephrine Injection (Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Currently in Shortage)
- Magnesium Sulfate Injection (Currently in Shortage)
- Morphine Sulfate (Astramorph PF, Duramorph, Infumorph) Injection (Preservative Free) (Currently in Shortage)
- Potassium Chloride Injection (Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Currently in Shortage)
- Sodium Chloride 23.4% Injection (Currently in Shortage)
- Succinylcholine (Anectine, Quelicin) Injection (Currently in Shortage)
- Vitamin A Palmitate (Aquasol A) Injection (Currently in Shortage)
- Pediatric Medical, Statistical, and Clinical Pharmacology BPCA Reviews (updated)
New and Generic Drug Approvals
July 22, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Claritin Hives Relief Reditab | loratadine | Tablet, Orally Disintegrating;Oral | Schering Plough | Labeling Revision |
| Claritin Reditabs | loratadine | Tablet, Orally Disintegrating;Oral | Schering Plough | Labeling Revision |
| Claritin Reditabs | loratadine | Tablet, Orally Disintegrating;Oral | Schering Plough | Labeling Revision |
| Cytoxan | cyclophosphamide | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Cytoxan (Lyophilized) | cyclophosphamide | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Desonate | desonide | Gel;Topical | Bayer Hlthcare | Labeling Revision |
| Lotensin Hct | benazepril hydrochloride; hydrochlorothiazide | Tablet;Oral | Us Pharms Holdings I | Manufacturing Change or Addition |
| Lyophilized Cytoxan | cyclophosphamide | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Otezla | apremilast | Tablet;Oral | Celgene Corp | Manufacturing Change or Addition |
| Ryanodex | dantrolene sodium | Suspension;Injectable | Eagle Pharms | Approval |
| Solu-Cortef | hydrocortisone sodium succinate | Injectable;Injection | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Solu-Medrol | methylprednisolone sodium succinate | Injectable;Injection | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Tacrolimus | tacrolimus | Capsule;Oral | Strides Arcolab Ltd | Approval |
| Teveten | eprosartan mesylate | Tablet;Oral | Abbvie | Labeling Revision |
| Teveten Hct | eprosartan mesylate; hydrochlorothiazide | Tablet;Oral | Abbvie | Labeling Revision |
| Xeloda | capecitabine | Tablet;Oral | Hoffmann La Roche | Manufacturing Change or Addition |
| Zoledronic Acid | zoledronic acid | Injectable;Injection | Sun Pharma Global | Tentative Approval |
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