What's New on the FDA Drugs Site
July 29, 2013
- FDA Drug Safety Podcast: FDA approves label changes for antimalarial drug mefloquine hydrochloride due to risk of serious psychiatric and nerve side effects
- FDA Drug Safety Podcast: FDA limits usage of Nizoral (ketoconazole) oral tablets due to potentially fatal liver injury and risk of drug interactions and adrenal gland problems
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Safety Communication: FDA approves label changes for antimalarial drug mefloquine hydrochloride due to risk of serious psychiatric and nerve side effects
- National Drug Code Directory
New and Generic Drug Approvals
July 26, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Abstral | fentanyl citrate | Tablet; Sublingual | Galena Biopharma | Labeling Revision |
| Armodafinil | armodafinil | Tablet; Oral | Lupin Ltd | Tentative Approval |
| Choline C-11 | choline c-11 | Injectable; Intravenous | Mcprf | Manufacturing Change or Addition |
| Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | Capsule, Extended Release; Oral | Par Pharm Inc | Tentative Approval |
| 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 |
| Doxepin Hydrochloride | doxepin hydrochloride | Tablet; Oral | Actavis Elizabeth | Approval |
| Duragesic-100 | fentanyl | Film, Extended Release; Transdermal | Janssen Pharms | Manufacturing Change or Addition |
| Duragesic-12 | fentanyl | Film, Extended Release; Transdermal | Janssen Pharms | Manufacturing Change or Addition |
| Duragesic-25 | fentanyl | Film, Extended Release; Transdermal | Janssen Pharms | Manufacturing Change or Addition |
| Duragesic-50 | fentanyl | Film, Extended Release; Transdermal | Janssen Pharms | Manufacturing Change or Addition |
| Duragesic-75 | fentanyl | Film, Extended Release; Transdermal | Janssen Pharms | Manufacturing Change or Addition |
| Fenofibrate (Micronized) | fenofibrate | Capsule; Oral | Apotex Inc | Approval |
| Inspra | eplerenone | Tablet; Oral | Gd Searle Llc | Manufacturing Change or Addition |
| Levocetirizine Dihydrochloride | levocetirizine dihydrochloride | Solution; Oral | Taro Pharm Inds | Approval |
| Mefloquine Hydrochloride | mefloquine hydrochloride | Tablet; Oral | Sandoz | Labeling Revision |
| Mefloquine Hydrochloride | mefloquine hydrochloride | Tablet; Oral | Barr | Labeling Revision |
| Mefloquine Hydrochloride | mefloquine hydrochloride | Tablet; Oral | Roxane | Labeling Revision |
| Prozac | fluoxetine hydrochloride | Capsule; Oral | Eli Lilly and Co | Efficacy Supplement with Clinical Data to Support |
| Prozac | fluoxetine hydrochloride | Capsule; Oral | Eli Lilly and Co | Labeling Revision |
| Prozac Weekly | fluoxetine hydrochloride | Capsule, Delayed Rel Pellets; Oral | Lilly | Labeling Revision |
| Ramelteon | ramelteon | Tablet; Oral | Teva Pharms Usa | Approval |
| Sarafem | fluoxetine hydrochloride | Capsule; Oral | Eli Lilly and Co | Efficacy Supplement with Clinical Data to Support |
| Sarafem | fluoxetine hydrochloride | Capsule; Oral | Eli Lilly and Co | Labeling Revision |
| Symbyax | fluoxetine hydrochloride; olanzapine | Capsule; Oral | Lilly | Efficacy Supplement with Clinical Data to Support |
| Symbyax | fluoxetine hydrochloride; olanzapine | Capsule; Oral | Lilly | Labeling Revision |
| Zyprexa | olanzapine | Tablet; Oral | Lilly | Efficacy Supplement with Clinical Data to Support |
| Zyprexa Zydis | olanzapine | Tablet, Orally Disintegrating; Oral | Lilly | Efficacy Supplement with Clinical Data to Support |
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