New Drug Approvals Archive - 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.
Read more: Alinia (nitazoxanide) FDA Approval History
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.
Metvixia (methyl aminolevulinate hydrochloride)
New Formulation Approved: June 26, 2008
Labeling Revision Approved: January 24, 2012
- New FDA Approved Labeling For Vytorin (ezetimibe/simvastatin) Includes Results From the Study of Heart and Renal Protection (SHARP) in Patients With Moderate to Severe Chronic Kidney Disease