New Drug Approvals Archive
New Drug Approvals: July 2008
| July 1 | Aciphex (rabeprazole)
Patient Population Altered: June 30, 2008 FDA Approves Aciphex (rabeprazole sodium) 20 mg for Short-Term Treatment of GERD in Adolescents |
| July 1 | FDA Approves First Generic Risperidone to Treat Psychiatric Conditions |
| July 3 | FDA Approves Abbott's Xience V Drug Eluting Stent |
| July 3 | GeneraMedix Inc. Receives Approval for Epoprostenol for Injection 1.5 mg |
| July 8 | Eovist (gadoxetate disodium) Date of Approval: July 3, 2008 Company: Bayer HealthCare Pharmaceuticals Inc. Treatment for Diagnostic Eovist (gadoxetate disodium) is a gadolinium-based contrast agent for intravenous use in T1-weighted magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adults with known or suspected focal liver disease. FDA Approves Eovist to Detect and Characterize Focal Liver Lesions |
| July 8 | FDA Grants Invitrogen Premarket Approval of Breast Cancer Test |
| July 14 | Roxane Laboratories, Inc. Announces the Approval of Morphine Sulfate Tablets and Oral Solution |
| July 18 | FDA Grants Clearance for Celera's ViroSeq HIV-1 Genotyping System Software v2.8 |
| July 24 | Navstel (balanced salt ophthalmic solution with hypromellose, dextrose and glutathione) Intraocular Irrigating Solution Date of Approval: July 24, 2008 Company: Alcon Laboratories, Inc. Treatment for Intraocular Irrigation Navstel is a balanced salt ophthalmic solution for use as an intraocular irrigation during surgical procedures involving perfusion of the eye. FDA Approves Navstel Intraocular Irrigating Solution |
| July 30 | Stavzor (valproic acid) Capsules Date of Approval: July 29, 2008 Company: Noven Pharmaceuticals, Inc. Treatment for Bipolar Disorder, Seizures, Epilepsy, Migraine Prophylaxis Stavzor is delayed-release valproic acid formulated in the EnteriCare enteric soft gelatin capsule delivery system designed to minimize GI adverse events. Stavzor is indicated for the treatment of manic episodes associated with bipolar disorder, adjunctive therapy in multiple seizure types (including epilepsy), and prophylaxis of migraine headaches. Noven Announces Final FDA Approval of Stavzor for the Treatment of Bipolar Disorder, Seizures and Migraine Headaches |
New Drug Approvals Archive
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