What's New on the FDA Drugs Site
August 16, 2013
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Safety Podcast: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection
- Medication Guides (updated)
- National Drug Code Directory
- Prescription Drug User Fee Act (PDUFA): FY 2014 Product and Establishment Fee Invoices were mailed on 8/15/2013. Full payment of the invoice is due 10/1/2013. If you do not receive your invoice by 8/28/2013, contact Ashley Jones or Beverly Friedman at 301-796-7900.
New and Generic Drug Approvals
August 15, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Actoplus Met | metformin hydrochloride; pioglitazone hydrochloride | Tablet; Oral | Takeda Pharms Usa | Manufacturing Change or Addition |
| Advil | ibuprofen sodium | Tablet; Oral | Pfizer Cons Hlthcare | Manufacturing Change or Addition |
| Ceenu | lomustine | Capsule; Oral | Corden Pharma | Labeling Revision |
| Delflex W/ Dextrose 1.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 1.5% Low Magnesium In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 2.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 2.5% Low Magnesium In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 4.25% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 4.25% Low Magnesium In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Glucovance | glyburide; metformin hydrochloride | Tablet; Oral | Bristol Myers Squibb | Manufacturing Change or Addition |
| Humalog | insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humalog Kwikpen | insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 50/50 | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 50/50 Kwikpen | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 50/50 Pen | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 75/25 | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 75/25 Kwikpen | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 75/25 Pen | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humalog Pen | insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humulin 70/30 | insulin recombinant human; insulin susp isophane recombinant human | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humulin 70/30 Pen | insulin recombinant human; insulin susp isophane recombinant human | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humulin N | insulin susp isophane recombinant human | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humulin R | insulin recombinant human | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humulin R Pen | insulin recombinant human | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Naproxen and Esomeprazole Magnesium | naproxen and esomeprazole magnesium | Tablet, Delayed Release; Oral | Dr Reddys Labs Ltd | Tentative Approval |
| Nesina | alogliptin benzoate | Tablet; Oral | Takeda Pharms Usa | Manufacturing Change or Addition |
| Oseni | alogliptin benzoate; pioglitazone hydrochloride | Tablet; Oral | Takeda Pharms Usa | Manufacturing Change or Addition |
| Reyataz | atazanavir sulfate | Capsule; Oral | Bristol Myers Squibb | Labeling Revision |
| Suclear | magnesium sulfate; polyethylene glycol 3350; potassium chloride; potassium sulfate; sodium bicarbonate; sodium chloride; sodium sulfate | Solution; Oral | Braintree Labs | Manufacturing Change or Addition |
| Taxotere | docetaxel | Injectable; Injection | Sanofi Aventis Us | Manufacturing Change or Addition |
| Truvada | emtricitabine; tenofovir disoproxil fumarate | Tablet; Oral | Gilead | Manufacturing Change or Addition |
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