New Drug Approvals Archive

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July 2008

July 1

Aciphex (rabeprazole)

Patient Population Altered: June 30, 2008

July 3

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.

Eovist (gadoxetate disodium) FDA Approval History

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.

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

July 29

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.

Stavzor (valproic acid) FDA Approval History

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