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New Drug Approvals Archive - July 2004

July 2004

Alinia (nitazoxanide) Tablets

Date of Approval: July 21, 2004
Company: Romark Laboratories
Treatment for: Traveler's Diarrhea

Alinia (nitazoxanide) is an antiprotozoal agent indicated for the treatment of diarrhea caused by Giardia lamblia in patients 12 years of age and older.

Vytorin (ezetimibe/simvastatin) Tablets

Date of Approval: July 23, 2004
Company: Merck/Schering-Plough Pharmaceuticals
Treatment for: Heterozygous Familial Hypercholesterolemia, Homozygous Familial Hypercholesterolemia

Vytorin (ezetimibe/simvastatin) is a combination of ezetimibe (a lipid-lowering compound) and simvastatin (an HMG-CoA reductase inhibitor) for the treatment of high LDL cholesterol (LDL-C) in patients with primary hypercholesterolemia or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough.

Metvixia (methyl aminolevulinate hydrochloride) Cream

Date of Approval: July 27, 2004
Company: PhotoCure ASA
Treatment for: Keratosis

Metvixia (methyl aminolevulinate hydrochloride) is a porphyrin precursor used in combination with the Aktilite CL128 lamp for treatment of actinic keratoses.

Campral (acamprosate calcium) Delayed-Release Tablets

Date of Approval: July 29, 2004
Company: Allergan, Inc.
Treatment for: Alcohol Dependence

Campral (acamprosate calcium) is a synthetic compound resembling the endogenous amino acid homotaurine indicated for treating alcohol dependence.

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