What's New on the FDA Drugs Site
September 18, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages: New and Updated
- Ammonium Chloride Injection (Currently in Shortage)
- Bupivacaine Hydrochloride (Marcaine, Sensorcaine) Injection (Currently in Shortage)
- Cefazolin Injection (Currently in Shortage)
- Clindamycin Phosphate (Cleocin) Injection (Currently in Shortage)
- Dextrose 5% Injection Bags (Currently in Shortage)
- Erythrocin Lactobionate Lyophilized Powder for Injection (Currently in Shortage)
- Heparin Sodium Injection (Currently in Shortage)
- Irrigation Solutions (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)
- Nalbuphine Hydrochloride (Nubain) Injection (Currently in Shortage)
- Ondansetron (Zofran) Injection (Currently in Shortage)
- Pancuronium Bromide Injection (Currently in Shortage)
- Piperacillin and Tazobactam (Zosyn) Injection (Currently in Shortage)
- Potassium Chloride Injection (Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Currently in Shortage)
- Sterile Water for Injection Solutions (New - Currently in Shortage)
- Tobramycin Solution for Injection (Currently in Shortage)
- Manual of Policies and Procedures (MAPP)
- MedWatch Safety Alert - Potassium Chloride Injection (Baxter): Recall - Shipping Carton Mislabeling
- National Drug Code Directory
New and Generic Drug Approvals
September 17, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Amoxapine | amoxapine | Tablet;Oral | Watson Labs | Labeling Revision |
| Citalopram Hydrobromide | citalopram hydrobromide | Solution;Oral | Roxane | Labeling Revision |
| Daliresp | roflumilast | Tablet;Oral | Forest Res Inst Inc | Manufacturing Change or Addition |
| Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Docetaxel | docetaxel | Injectable;Injection | Actavis Inc | Labeling Revision |
| Lactated Ringer's In Plastic Container | calcium chloride; potassium chloride; sodium chloride; sodium lactate | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Serostim | somatropin recombinant | Injectable;Injection | Emd Serono | Manufacturing Change or Addition |
| Serostim Lq | somatropin recombinant | Injectable;Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| Sodium Chloride 0.45% In Plastic Container | sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Sodium Chloride 0.9% In Plastic Container | sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Stendra | avanafil | Tablet;Oral | Vivus | Efficacy Supplement with Clinical Data to Support |
| Tofranil | imipramine hydrochloride | Tablet;Oral | Mallinckrodt Inc | Labeling Revision |
| Venlafaxine Hydrochloride | venlafaxine hydrochloride | Tablet;Oral | Teva | Labeling Revision |
| Vivactil | protriptyline hydrochloride | Tablet;Oral | Odyssey Pharms | Labeling Revision |
| This email was sent to kostikblog@ukr.net using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
