What's New on the FDA Drugs Site
February 28, 2013
- Current Drug Shortages Index (updated)
- Drugs@FDA Data Files (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- FDA approves Osphena for postmenopausal women experiencing pain during sex
- National Drug Code Directory (updated)
New and Generic Drug Approvals
February 27, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Depacon | valproate sodium | Injectable; Injection | Abbvie | Labeling Revision |
| Depakene | valproic acid | Capsule; Oral | Abbvie | Labeling Revision |
| Depakene | valproic acid | Syrup; Oral | Abbvie | Labeling Revision |
| Depakote | divalproex sodium | Tablet, Delayed Release; Oral | Abbvie | Labeling Revision |
| Depakote | divalproex sodium | Capsule, Delayed Rel Pellets; Oral | Abbvie | Labeling Revision |
| Depakote Er | divalproex sodium | Tablet, Extended Release; Oral | Abbvie | Labeling Revision |
| Dexbrompheniramine Maleate and Pseudoephedrine Sulfate | dexbrompheniramine maleate; pseudoephedrine sulfate | Tablet, Extended Release; Oral | Avanthi Inc | Approval |
| Eligard | leuprolide acetate | Injectable; Subcutaneous | Tolmar Therap | Labeling Revision |
| Eligard | leuprolide acetate | Injectable; Subcutaneous | Tolmar Therap | Labeling Revision |
| Eligard | leuprolide acetate | Injectable; Subcutaneous | Tolmar Therap | Labeling Revision |
| Eligard | leuprolide acetate | Injectable; Subcutaneous | Tolmar Therap | Labeling Revision |
| Gemcitabine | gemcitabine hydrochloride | Injectable; Injection | Sagent Pharms | Tentative Approval |
| Intelence | etravirine | Tablet; Oral | Janssen R and D | Labeling Revision |
| Irbesartan and Hydrochlorothiazide | hydrochlorothiazide; irbesartan | Tablet; Oral | Lupin Ltd | Approval |
| Irbesartan and Hydrochlorothiazide | hydrochlorothiazide; irbesartan | Tablet; Oral | Lupin Ltd | Tentative Approval |
| Irbesartan; Hydrochlorothiazide | irbesartan; hydrochlorothiazide | Tablet; Oral | Lupin Ltd | Approval |
| Irbesartan; Hydrochlorothiazide | irbesartan; hydrochlorothiazide | Tablet; Oral | Lupin Ltd | Tentative Approval |
| Malarone | atovaquone; proguanil hydrochloride | Tablet; Oral | Glaxosmithkline | Labeling Revision |
| Malarone Pediatric | atovaquone; proguanil hydrochloride | Tablet; Oral | Glaxosmithkline | Labeling Revision |
| Prosol 20% Sulfite Free In Plastic Container | amino acids | Injectable; Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Quetiapine Fumarate | quetiapine fumarate | Tablet; Oral | Actavis Pharma | Approval |
| Rifadin | rifampin | Capsule; Oral | Sanofi Aventis Us | Labeling Revision |
| Rifadin | rifampin | Injectable; Injection | Sanofi Aventis Us | Labeling Revision |
| Rifater | isoniazid; pyrazinamide; rifampin | Tablet; Oral | Sanofi Aventis Us | Labeling Revision |
| Topiramate | topiramate | Tablet; Oral | Activis Totowa Llc | Approval |
| Urso 250 | ursodiol | Tablet; Oral | Aptalis Pharma Us | Manufacturing Change or Addition |
| Urso Forte | ursodiol | Tablet; Oral | Aptalis Pharma Us | Manufacturing Change or Addition |
| Xolegel | ketoconazole | Gel; Topical | Aqua Pharms | Manufacturing Change or Addition |
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