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New Drug Approvals Archive

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July 2004

July 21

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.

Alinia (nitazoxanide) FDA Approval History

July 23

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.

Vytorin (ezetimibe/simvastatin) FDA Approval History

July 27

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.

Metvixia (methyl aminolevulinate hydrochloride) FDA Approval History

July 29

Campral (acamprosate calcium) Delayed-Release Tablets

Date of Approval: July 29, 2004
Company: Forest Laboratories, Inc. and Merck
Treatment for: Alcohol Dependence

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

Campral (acamprosate calcium) FDA Approval History

June 27

Metvixia (methyl aminolevulinate hydrochloride)

New Formulation Approved: June 26, 2008

Metvixia (methyl aminolevulinate hydrochloride) FDA Approval History

January 25

Vytorin (ezetimibe/simvastatin)

Labeling Revision Approved: January 24, 2012

Vytorin (ezetimibe/simvastatin) FDA Approval History

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