What's New on the FDA Drugs Site
September 29, 2014
- Manual of Policies and Procedures (MAPP) 7600.11 CDER System of Record, (PDF - 104KB)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages: New and Updated
- Haloperidol Lactate Injection (Currently in Shortage)
- Methylphenidate Hydrochloride ER Capsules/Tablets (Currently in Shortage)
- Methylphenidate Hydrochloride Tablets (Currently in Shortage)
- Piperacillin and Tazobactam (Zosyn) Injection (Currently in Shortage)
- Sincalide (Kinevac) Lyophilized Powder for Injection (Currently in Shortage)
- FDA warns consumers not to use Eu Yan Sang (Hong Kong) Ltd.’s “Bo Ying compound"
- National Drug Code Directory
- Warning Letters 2014 (updated)
New and Generic Drug Approvals
September 26, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Acetic Acid 0.25% In Plastic Container | acetic acid, glacial | Solution;Irrigation, Urethral | Baxter Hlthcare | Manufacturing Change or Addition |
| Allopurinol | allopurinol | Tablet;Oral | Watson Labs | Manufacturing Change or Addition |
| Aminoacetic Acid 1.5% In Plastic Container | glycine | Solution;Irrigation | Baxter Hlthcare | Manufacturing Change or Addition |
| Cubicin | daptomycin | Injectable;Iv (Infusion) | Cubist | Manufacturing Change or Addition |
| Dextrose 5% In Sodium Chloride 0.2% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Dextrose 5% In Sodium Chloride 0.33% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Dextrose 5%, Sodium Chloride 0.45% and Potassium Chloride 15meq In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Dextrose 5%, Sodium Chloride 0.45% and Potassium Chloride 20meq (K) In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Dextrose 5%, Sodium Chloride 0.45% and Potassium Chloride 5meq In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Diclofenac Sodium | diclofenac sodium | Spray;Topical | Watson Labs | Tentative Approval |
| Diovan | valsartan | Tablet;Oral | Novartis | Labeling Revision |
| Elidel | pimecrolimus | Cream;Topical | Valeant Bermuda | Manufacturing Change or Addition |
| Firmagon | degarelix acetate | Powder;Subcutaneous | Ferring | Manufacturing Change or Addition |
| Hicon | sodium iodide i-131 | Solution;Oral | Jubilant Draximage | Manufacturing Change or Addition |
| Lactated Ringer's In Plastic Container | calcium chloride; potassium chloride; sodium chloride; sodium lactate | Solution;Irrigation | Baxter Hlthcare | Manufacturing Change or Addition |
| Letairis | ambrisentan | Tablet;Oral | Gilead | Manufacturing Change or Addition |
| Linezolid | linezolid sodium chloride | Injectable;Injection | Hospira Inc | Tentative Approval |
| Lluvien | fluocinolone acetonide | Insert;Intravitreal | Alimera Sciences Inc | Approval |
| Loestrin 21 1.5/30 | ethinyl estradiol; norethindrone acetate | Tablet;Oral-21 | Warner Chilcott Llc | Manufacturing Change or Addition |
| Loestrin 21 1/20 | ethinyl estradiol; norethindrone acetate | Tablet;Oral-21 | Warner Chilcott Llc | Manufacturing Change or Addition |
| Loestrin Fe 1/20 | ethinyl estradiol; norethindrone acetate | Tablet;Oral-28 | Warner Chilcott | Manufacturing Change or Addition |
| Mekinist | trametinib dimethyl sulfoxide | Tablet;Oral | Glaxosmithkline Llc | Manufacturing Change or Addition |
| Mitigare | colchicine | Capsule;Oral | Hikma Pharms Llc | Approval |
| Namenda Xr | memantine hydrochloride | Capsule, Extended Release;Oral | Forest Labs | Labeling Revision |
| Potassium Chloride 10meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Potassium Chloride 20meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Potassium Chloride 30meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Potassium Chloride 40meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Potassium Chloride 5meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Protonix Iv | pantoprazole sodium | Injectable;Iv (Infusion) | Wyeth Pharms Inc | Manufacturing Change or Addition |
| Qsymia | phentermine hydrochloride; topiramate | Capsule, Extended Release;Oral | Vivus | Labeling Revision |
| Qsymia | phentermine hydrochloride; topiramate | Capsule, Extended Release;Oral | Vivus | Supplement |
| Sodium Iodide I-131 | sodium iodide i-131 | Capsule;Oral | Jubilant Draximage | Manufacturing Change or Addition |
| Sterile Water For Injection In Plastic Container | sterile water for injection | Liquid;N/A | Baxter Hlthcare | Manufacturing Change or Addition |
| Sterile Water In Plastic Container | sterile water for irrigation | Liquid;Irrigation | Baxter Hlthcare | Manufacturing Change or Addition |
| Tagamet Hb | cimetidine | Tablet;Oral | Medtech Prods | Manufacturing Change or Addition |
| Xolair | omalizumab | Vial | Genentech | Efficacy Supplement with Clinical Data to Support |
| Zenpep | pancrelipase (amylase;lipase;protease) | Capsule, Delayed Release;Oral | Forest Labs Inc | Manufacturing Change or Addition |
| Zutripro | chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride | Solution;Oral | Cypress Pharm | Manufacturing Change or Addition |
| Zyrtec Allergy | cetirizine hydrochloride | Tablet;Oral | Mcneil Consumer | Manufacturing Change or Addition |
| Zyrtec Hives Relief | cetirizine hydrochloride | Tablet;Oral | Mcneil Consumer | Manufacturing Change or Addition |
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