Here is an update on drug product research from my reading –

On November 5, 2009, the U.S. Food and Drug Administration granted approval to romidepsin for injection (ISTODAX, Gloucester Pharmaceuticals Inc.) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.

The efficacy and safety of romidepsin were evaluated in two single-arm, multicenter, open label trials.  Efficacy was assessed in 167 patients with CTCL treated in the United States, Europe, and Australia. 

The recommended dose and schedule of romidepsin is 14 mg/m2 intravenously over 4 hours on days 1, 8 and 15 of a 28-day cycle. 

For further reading please visit : http://www.pharm-education.com/2009/11/update-on-romidepsin-formulation.html
Add Comment