What's New on the FDA Drugs Site
September 30, 2014
-
FDA Drug Shortages: New and Updated
- Rifampin for Injection (Currently in Shortage)
- Tobramycin Solution for Injection (Currently in Shortage)
-
Final PDUFA V Information Technology Plan” (FY 2013-2017) (PDF - 447KB)
New and Generic Drug Approvals
September 29, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Abilify Maintena Kit | aripiprazole | For Suspension, Extended Release;Intramuscular | Otsuka Pharm Co Ltd | Manufacturing Change or Addition |
| Alinia | nitazoxanide | For Suspension;Oral | Romark | Manufacturing Change or Addition |
| Clozaril | clozapine | Tablet;Oral | Novartis | Labeling Revision |
| Cortrosyn | cosyntropin | Injectable;Injection | Amphastar Pharms Inc | Manufacturing Change or Addition |
| Cozaar | losartan potassium | Tablet;Oral | Merck Sharp Dohme | Labeling Revision |
| Dextrose 5% In Plastic Container | dextrose | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Flo-Pred | prednisolone acetate | Suspension;Oral | Taro | Manufacturing Change or Addition |
| Fludarabine Phosphate | fludarabine phosphate | Injectable;Injection | Sandoz | Manufacturing Change or Addition |
| Hyzaar | hydrochlorothiazide; losartan potassium | Tablet;Oral | Merck Sharp Dohme | Labeling Revision |
| Lumigan | bimatoprost | Solution/Drops;Ophthalmic | Allergan | Labeling Revision |
| Lumigan | bimatoprost | Solution/Drops;Ophthalmic | Allergan | Labeling Revision |
| Nexterone | amiodarone hydrochloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Relistor | methylnaltrexone bromide | Injectable;Subcutaneous | Salix Pharms | Efficacy Supplement with Clinical Data to Support |
| Relistor | methylnaltrexone bromide | Solution;Subcutaneous | Salix Pharms | Efficacy Supplement with Clinical Data to Support |
| Skelaxin | metaxalone | Tablet;Oral | King Pharms | Manufacturing Change or Addition |
| Sodium Chloride 0.9% In Sterile Plastic Container | sodium chloride | Solution For Slush;Irrigation | Baxter Hlthcare | Manufacturing Change or Addition |
| Versacloz | clozapine | Suspension;Oral | Jazz Pharms Iii | Manufacturing Change or Addition |
| Voltaren | diclofenac sodium | Gel;Topical | Novartis | Manufacturing Change or Addition |
| Zingo | lidocaine hydrochloride | System;Intradermal | Powder Pharms | Manufacturing Change or Addition |
| Zovirax | acyclovir | Ointment;Topical | Valeant Bermuda | Manufacturing Change or Addition |
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