What's New on the FDA Drugs Site
August 10, 2012
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- FDA approves Lucentis (ranibizumab injection) to treat diabetic macular edema
New and Generic Drug Approvals
August 9, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Advair Diskus 100/50 | fluticasone propionate; salmeterol xinafoate | Powder; Inhalation | Glaxosmithkline | Labeling Revision |
| Advair Diskus 250/50 | fluticasone propionate; salmeterol xinafoate | Powder; Inhalation | Glaxosmithkline | Labeling Revision |
| Advair Diskus 500/50 | fluticasone propionate; salmeterol xinafoate | Powder; Inhalation | Glaxosmithkline | Labeling Revision |
| Advair Hfa | fluticasone propionate; salmeterol xinafoate | Aerosol, Metered; Inhalation | Glaxosmithkline | Labeling Revision |
| Amphetamine Sulfate | amphetamine sulfate | Tablet; Oral | Independence Pharma Llc | Approval |
| Brovana | arformoterol tartrate | Solution; Inhalation | Sunovion | Supplement |
| Clobetasol Propionate | clobetasol propionate | Shampoo; Topical | Perrigo | Approval |
| Diltiazem Hydrochloride | diltiazem hydrochloride | Injectable; Injection | Hikma Farmaceutica | Approval |
| Losartan Potassium; Hydrochlorothiazide | losartan potassium; hydrochlorothiazide | Tablet; Oral | Macleods Pharms Ltd | Approval |
| Marqibo | vincristine sulfate | Injectable, Liposomal; Injection | Talon Therapeutics | Approval |
| Serevent | salmeterol xinafoate | Powder; Inhalation | Glaxo Grp Ltd | Labeling Revision |
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