New Drug Approvals Archive - July 2008

Aciphex (rabeprazole)

Patient Population Altered: June 30, 2008

• FDA Approves Aciphex (rabeprazole sodium) 20 mg for Short-TermTreatment of GERD in Adolescents

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

Eovist (gadoxetate disodium) FDA Approval History

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

Navstel (balanced salt ophthalmic solution with hypromellose, dextrose and glutathione) FDA Approval History

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

Stavzor (valproic acid) FDA Approval History