What's New on the FDA Drugs Site
June 16, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
- Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between January – March 2014
New and Generic Drug Approvals
June 13, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Alli | orlistat | Capsule;Oral | Glaxosmithkline Cons | Labeling Revision |
| Azor | amlodipine besylate; olmesartan medoxomil | Tablet;Oral | Daiichi Sankyo | Labeling Revision |
| Benicar | olmesartan medoxomil | Tablet;Oral | Daiichi Sankyo | Labeling Revision |
| Benicar Hct | hydrochlorothiazide; olmesartan medoxomil | Tablet;Oral | Daiichi Sankyo | Labeling Revision |
| Bicnu | carmustine | Injectable;Injection | Emcure Pharms Ltd | Manufacturing Change or Addition |
| Codeine Sulfate | codeine sulfate | Tablet;Oral | Lannett Holdings Inc | Approval |
| Comtan | entacapone | Tablet;Oral | Orion Pharma | Labeling Revision |
| Differin | adapalene | Gel;Topical | Galderma Labs Lp | Manufacturing Change or Addition |
| Jetrea | ocriplasmin | Injectable; Intravitreal | Thrombogenics, Inc | Efficacy Supplement with Clinical Data to Support |
| Kalydeco | ivacaftor | Tablet;Oral | Vertex Pharms | Labeling Revision |
| Lymphoseek Kit | technetium tc-99m tilmanocept | Injectable;Injection | Navidea Biopharms | Efficacy Supplement with Clinical Data to Support |
| Renova | tretinoin | Cream;Topical | Valeant Intl | Manufacturing Change or Addition |
| Risedronate Sodium | risedronate sodium | Tablet; Oral | Teva Pharms | Approval |
| Sporanox | itraconazole | Capsule;Oral | Janssen Pharms | Manufacturing Change or Addition |
| Talc | talc | Powder;Intrapleural | Bryan | Labeling Revision |
| Tribenzor | amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil | Tablet;Oral | Daiichi Sankyo | Labeling Revision |
| Venofer | iron sucrose | Injectable;Intravenous | Luitpold | Manufacturing Change or Addition |
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