What's New on the FDA Drugs Site
August 17, 2012
- FDA approves first generic Actos (pioglitazone hydrochloride) to treat type 2 diabetes
- FDA MedWatch Safety Alert: Hospira Propofol Injectable Emulsion: Recall - Glass Vial Defect
New and Generic Drug Approvals
August 16, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Chloraprep One-Step | chlorhexidine gluconate; isopropyl alcohol | Sponge; Topical | Carefusion | Labeling Revision |
| Chloraprep One-Step Frepp | chlorhexidine gluconate; isopropyl alcohol | Sponge; Topical | Carefusion | Labeling Revision |
| Chloraprep One-Step Sepp | chlorhexidine gluconate; isopropyl alcohol | Swab; Topical | Cardinal Hlth | Labeling Revision |
| Chloraprep Single Swabstick | chlorhexidine gluconate; isopropyl alcohol | Swab; Topical | Cardinal Hlth | Labeling Revision |
| Chloraprep Triple Swabstick | chlorhexidine gluconate; isopropyl alcohol | Swab; Topical | Cardinal Hlth | Labeling Revision |
| Chloraprep With Tint | chlorhexidine gluconate; isopropyl alcohol | Sponge; Topical | Carefusion | Labeling Revision |
| Entacapone | entacapone | Tablet; Oral | Wockhardt Ltd | Approval |
| Strattera | atomoxetine hydrochloride | Capsule; Oral | Lilly | Labeling Revision |
| Tamiflu | oseltamivir phosphate | Capsule; Oral | Roche | Labeling Revision |
| Tamiflu | oseltamivir phosphate | For Suspension; Oral | Roche | Labeling Revision |
| Ultane | sevoflurane | Liquid; Inhalation | Abbott | Labeling Revision |
| Viread | tenofovir disoproxil fumarate | Tablet; Oral | Gilead Sciences Inc | Labeling Revision |
| Viread | tenofovir disoproxil fumarate | Powder; Oral | Gilead Sciences Inc | Labeling Revision |
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