What's New on the FDA Drugs Site
October 24, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- 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)
- Famotidine Injection (Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Currently in Shortage)
- Magnesium Sulfate Injection (Currently in Shortage)
- Phosphate (Glycophos) Injection (Currently in Shortage)
- Piperacillin and Tazobactam (Zosyn) Injection (Currently in Shortage)
- Potassium Chloride Injection (Currently in Shortage)
- Sodium Chloride 23.4% Injection (Currently in Shortage)
- Tobramycin Solution for Injection (Currently in Shortage)
- Guidance for Industry: Qualification of Biomarker--Galactomannan in studies of treatments of invasive Aspergillosis (PDF - 151KB)
- National Drug Code Directory
- Activities Report of the Generic Drug Program (FY 2014) (updated)
New and Generic Drug Approvals
October 23, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Abacavir and Lamivudine | abacavir;lamivudine | Tablet, For Suspension;Oral | Mylan Labs Ltd | Tentative Approval |
| Abacavir and Lamivudine | abacavir;lamivudine | Tablet;Oral | Mylan Labs Ltd | Tentative Approval |
| Adrenaclick | epinephrine | Injectable;Intramuscular, Subcutaneous | Amedra Pharms | Manufacturing Change or Addition |
| Astelin | azelastine hydrochloride | Spray, Metered;Nasal | Meda Pharms | Labeling Revision |
| Cancidas | caspofungin acetate | Injectable;Iv (Infusion) | Merck | Labeling Revision |
| Dilatrate-Sr | isosorbide dinitrate | Capsule, Extended Release;Oral | Auxilium Pharms Llc | Labeling Revision |
| Finacea | azelaic acid | Gel;Topical | Bayer Hlthcare | Manufacturing Change or Addition |
| Luvox | fluvoxamine maleate | Tablet;Oral | Ani Pharms | Manufacturing Change or Addition |
| Minocin | minocycline hydrochloride | Injectable;Injection | Rempex Pharms Inc | Labeling Revision |
| Phenylephrine Hydrochloride | phenylephrine hydrochloride | Solution;Iv (Infusion) | West Ward Pharm Corp | Manufacturing Change or Addition |
| Sodium Iodide I 131 | sodium iodide i-131 | Capsule;Oral | Mallinckrodt | Manufacturing Change or Addition |
| Somatuline Depot | lanreotide acetate | Injectable;Subcutaneous | Ipsen Pharma | Manufacturing Change or Addition |
| Tudorza Pressair | aclidinium bromide | Powder, Metered;Inhalation | Forest Labs Inc | Manufacturing Change or Addition |
| Twinject 0.15 | epinephrine | Injectable;Intramuscular, Subcutaneous | Amedra Pharms | Manufacturing Change or Addition |
| Twinject 0.3 | epinephrine | Injectable;Intramuscular, Subcutaneous | Amedra Pharms | Manufacturing Change or Addition |
| Uloric | febuxostat | Tablet;Oral | Takeda Pharms Usa | Manufacturing Change or Addition |
| Zetonna | ciclesonide | Aerosol, Metered;Nasal | Takeda Gmbh | Efficacy Supplement with Clinical Data to Support |
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