What's New on the FDA Drugs Site
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Safety Communication: FDA approves label changes for asthma drug Xolair (omalizumab), including describing slightly higher risk of heart and brain adverse events
- FDA Drug Shortages: New and Updated
- Bupivacaine Hydrochloride (Marcaine, Sensorcaine) Injection (Currently in Shortage)
- Calcium Gluconate Injection (Currently in Shortage)
- Clindamycin Phosphate (Cleocin) Injection (Currently in Shortage)
- Clonidine HCL Injection (Duraclon) (Currently in Shortage)
- Cyanocobalamin (Vitamin B12) Injection (Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Currently in Shortage)
- Heparin Sodium Injection (Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Currently in Shortage)
- Sodium Chloride 23.4% Injection (Currently in Shortage)
- Tobramycin Solution for Injection (Currently in Shortage)
- National Drug Code Directory
New and Generic Drug Approvals
September 25, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Abacavir Sulfate; Lamivudine | abacavir sulfate;lamivudine | Tablet;Oral | Hetero Labs Ltd V | Tentative Approval |
| Betoptic | betaxolol hydrochloride | Solution/Drops;Ophthalmic | Alcon | Manufacturing Change or Addition |
| Brovana | arformoterol tartrate | Solution;Inhalation | Sunovion | Manufacturing Change or Addition |
| Dextrose 5% and Potassium Chloride 0.075% In Plastic Container | dextrose; potassium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Dextrose 5% and Potassium Chloride 0.15% In Plastic Container | dextrose; potassium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Dextrose 5% and Potassium Chloride 0.224% In Plastic Container | dextrose; potassium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Dextrose 5% and Potassium Chloride 0.3% In Plastic Container | dextrose; potassium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Fludeoxyglucose F 18 | fludeoxyglucose f 18 | Injectable;Injection | Massachusetts General Hosp | Approval |
| Genotropin | somatropin recombinant | Injectable;Injection | Pharmacia and Upjohn | Labeling Revision |
| Genotropin Preservative Free | somatropin recombinant | Injectable;Injection | Pharmacia and Upjohn | Labeling Revision |
| Minocycline Hydrochloride | minocycline hydrochloride | Tablet, Extended Release;Oral | Ranbaxy Labs Ltd | Approval |
| Mitosol | mitomycin | For Solution;Topical | Mobius Therap | Labeling Revision |
| Norditropin | somatropin recombinant | Injectable;Injection | Novo Nordisk Inc | Labeling Revision |
| Norditropin Flexpro | somatropin recombinant | Injectable;Injection | Novo Nordisk Inc | Labeling Revision |
| Norditropin Nordiflex | somatropin recombinant | Injectable;Injection | Novo Nordisk Inc | Labeling Revision |
| Phentermine Hydrochloride | phentermine hydrochloride | Tablet;Oral | Ken Lifescience | Approval |
| Phentermine Hydrochloride | phentermine hydrochloride | Capsule;Oral | Ken Lifescience | Approval |
| Premarin | estrogens, conjugated | Cream;Topical, Vaginal | Wyeth Pharms Inc | Manufacturing Change or Addition |
| Qoliana | brimonidine tartrate | Solution/Drops;Ophthalmic | Alcon Pharms Ltd | Manufacturing Change or Addition |
| Tasigna | nilotinib hydrochloride monohydrate | Capsule;Oral | Novartis | Labeling Revision |
| Timolol Maleate | timolol maleate | Solution, Gel Forming/Drops;Ophthalmic | Falcon Pharms | Manufacturing Change or Addition |
| Uceris | budesonide | Tablet, Extended Release;Oral | Santarus Inc | Manufacturing Change or Addition |
| Zinacef | cefuroxime sodium | Injectable;Injection | Covis Injectables | Labeling Revision |
| Zinacef | cefuroxime sodium | Injectable;Intramuscular, Intravenous | Covis Injectables | Labeling Revision |
| Zinacef In Plastic Container | cefuroxime sodium | Injectable;Injection | Covis Injectables | Labeling Revision |
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