What's New on the FDA Drugs Site
June 25, 2012
- Small Business Chronicles (updated)
New and Generic Drug Approvals
June 22, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Cellcept | mycophenolate mofetil | Capsule; Oral | Roche Palo | Labeling Revision |
| Cellcept | mycophenolate mofetil hydrochloride | Injectable; Injection | Roche Palo | Labeling Revision |
| Cellcept | mycophenolate mofetil | Suspension; Oral | Roche Palo | Labeling Revision |
| Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | Capsule, Extended Release; Oral | Actavis Elizabeth | Approval |
| Incivek | telaprevir | Tablet; Oral | Vertex Pharms | Labeling Revision |
| Inspra | eplerenone | Tablet; Oral | Gd Searle Llc | Labeling Revision |
| Myfortic | mycophenolic acid | Tablet, Delayed Release; Oral | Novartis | Labeling Revision |
| Normocarb Hf 25 | magnesium chloride; sodium bicarbonate; sodium chloride | Solution; Injection | Dialysis Sups | Labeling Revision |
| Normocarb Hf 35 | magnesium chloride; sodium bicarbonate; sodium chloride | Solution; Injection | Dialysis Sups | Labeling Revision |
| Sustiva | efavirenz | Capsule; Oral | Bristol Myers Squibb | Labeling Revision |
| Sustiva | efavirenz | Tablet; Oral | Bristol Myers Squibb | Labeling Revision |
| Temazepam | temazepam | Capsule; Oral | Novel Labs Inc | Chemistry New Strength |
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