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Barr Laboratories has received final approval from the FDA for its application to manufacture and market Clonazepam Orally Disintegrating Tablets in 0.125-mg, 0.25-mg, 0.5-mg, 1-mg and 2-mg dosage strengths.
Myogen has announced the publication of the results from a Phase II trial of ambrisentan in patients with pulmonary arterial hypertension (PAH) in this month's issue of the Journal of the American College of Cardiology.
Migenex has received a Notice of Authorization from Health Canada for a clinical trial application to begin a Phase IIb combination study of MX-3253 (celgosivir), a compound in development for the treatment of chronic hepatitis C virus (HCV) infections.
Advanced Magnetics announced that after a recent meeting with the FDA to evaluate its Phase III development program for ferumoxytol in IV iron replacement therapy, the company plans to revise the program to include a new primary efficacy analysis suggested by the FDA.
Join FDAnews Thursday, Aug. 18, for "Cross-Labeling Combination Products: Case Studies and Strategies for Success." David Fox and Jeffrey Shapiro will discuss primary modes of action and cross-labeling two of today's most divisive regulatory issues affecting combination products. On Aug. 31, join FDAnews for "Step-By-Step Guide to Clinical Trials: Effectively Execute a Study From Design to Audit." Gather your team together to learn from expert William Sietsema, Ph.D., as he guides you step by step on the best ways to execute a clinical trial from how to engineer a clinical program and organize a project team to what to do if your site is audited
by the FDA.
United Research Laboratories and Mutual Pharmaceutical have announced that Mutual Pharmaceutical has received FDA approval of its abbreviated new drug application (ANDA) for folic acid 1mg tablets.