New Drug Approvals Archive - July 2004
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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: Allergan, Inc. 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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