What's New on the FDA Drugs Site
August 30, 2012
- FDA Drug Safety Communication: FDA recommends against use of Revatio in children with pulmonary hypertension
- FDA grants accelerated approval to Afinitor Disperz, a new pediatric formulation of everolimus
New and Generic Drug Approvals
August 29, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Afinitor | everolimus | Tablet; Oral | Novartis | Labeling Revision |
| Armodafinil | armodafinil | Tablet; Oral | Watson Labs Inc | Approval |
| Atrovent Hfa | ipratropium bromide | Aerosol, Metered; Inhalation | Boehringer Ingelheim | Labeling Revision |
| Bactrim | sulfamethoxazole; trimethoprim | Tablet; Oral | Mutual Pharm | Labeling Revision |
| Bactrim Ds | sulfamethoxazole; trimethoprim | Tablet; Oral | Mutual Pharm | Labeling Revision |
| Caffeine Citrate | caffeine citrate | Solution; Intravenous | Sagent Pharms | Approval |
| Caffeine Citrate | caffeine citrate | Solution; Oral | Sagent Pharms | Approval |
| Cimzia | certolizumab pegol | Injectable; Injection | Ucb Inc | Labeling Revision |
| Combivent Respimat | albuterol sulfate; ipratropium bromide | Spray, Metered; Inhalation | Boehringer Ingelheim | Labeling Revision |
| Invega Sustenna | paliperidone palmitate | Suspension, Extended Release; Intramuscular | Janssen Pharms | Efficacy Supplement with Clinical Data to Support |
| Moviprep | ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | For Solution; Oral | Salix Pharms | Labeling Revision |
| Neutroval | tbo-filgrastim | Injectable; Injection | Sicor Biotech | Labeling Revision |
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