What's New on the FDA Drugs Site
October 16, 2013
- Current Drug Shortages Index (updated)
- FDA advises against using oral ketoconazole in drug interaction studies due to serious potential side effects
- Guidance for Industry:
- Drug Firm Annual Registration Status (updated)
- Drugs@FDA Data Files (updated)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (FDASIA/BPCA) (updated)
October 15, 2013
- Guidance for Industry:
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
New and Generic Drug Approvals
October 15, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Diabeta | glyburide | Tablet;Oral | Sanofi Aventis Us | Labeling Revision |
| Glucotrol | glipizide | Tablet;Oral | Pfizer | Labeling Revision |
| Glucotrol Xl | glipizide | Tablet, Extended Release;Oral | Pfizer | Labeling Revision |
| Glucovance | glyburide; metformin hydrochloride | Tablet;Oral | Bristol Myers Squibb | Labeling Revision |
| Glynase | glyburide | Tablet;Oral | Pharmacia and Upjohn | Labeling Revision |
| Metaglip | glipizide; metformin hydrochloride | Tablet;Oral | Bristol Myers Squibb | Labeling Revision |
| Micronase | glyburide | Tablet;Oral | Pharmacia and Upjohn | Labeling Revision |
October 14, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Cipro In Dextrose 5% In Plastic Container | ciprofloxacin | Injectable;Injection | Bayer Hlthcare | Manufacturing Change or Addition |
| Norditropin | somatropin recombinant | Injectable;Injection | Novo Nordisk Inc | Labeling Revision |
| Norditropin Flexpro | somatropin recombinant | Injectable;Injection | Novo Nordisk Inc | Labeling Revision |
| Norditropin Nordiflex | somatropin recombinant | Injectable;Injection | Novo Nordisk Inc | Labeling Revision |
October 11, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Acyclovir Sodium | acyclovir sodium | Injectable;Injection | Aurobindo Pharma Ltd | Approval |
| Bupropion Hydrochloride | bupropion hydrochloride | Tablet, Extended Release;Oral | Jubilant Life | Approval |
| Bupropion Hydrochloride | bupropion hydrochloride | Tablet, Extended Release;Oral | Jubilant Life | Approval |
| Comtan | entacapone | Tablet;Oral | Orion Pharma | Manufacturing Change or Addition |
| Depo-Medrol | methylprednisolone acetate | Injectable;Injection | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Desvenlafaxine | desvenlafaxine fumarate | Tablet, Extended Release;Oral | Teva Pharms Usa | Approval |
| Entecavir | entecavir | Tablet; Oral | Teva Pharms Usa | Tentative Approval |
| Frova | frovatriptan succinate | Tablet;Oral | Endo Pharms | Labeling Revision |
| Monodox | doxycycline | Capsule;Oral | Aqua Pharms | Labeling Revision |
| Nasacort Aq | triamcinolone acetonide | Spray, Metered;Nasal | Sanofi Aventis Us | OTC Labeling |
| Nicorette | nicotine polacrilex | Gum, Chewing;Buccal | Glaxosmithkline | Manufacturing Change or Addition |
| Nicorette (Mint) | nicotine polacrilex | Gum, Chewing;Buccal | Glaxosmithkline | Manufacturing Change or Addition |
| Otrexup | methotrexate | Injectable; Suspension | Antares Pharma, Inc. | Approval |
| Penicillin V Potassium | penicillin v potassium | Tablet;Oral | Hikma Pharms | Approval |
| Somavert | pegvisomant | Injectable;Subcutaneous | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Vimpat | lacosamide | Tablet;Oral | Ucb Inc | Manufacturing Change or Addition |
| Zmax | azithromycin | For Suspension, Extended Release;Oral | Pf Prism Cv | Labeling Revision |
| Zonegran | zonisamide | Capsule;Oral | Eisai Inc | Manufacturing Change or Addition |
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