Drugs in the making.com
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
Disclaimer : The above information is for dissemination of knowledge only and should not be construed as medical advise. The scientific data presented here has been studied from leading publications already in public domain. The author however, assumes no responsibility regarding trueness of the data. Reference to stated journals and websites is encouraged in case of additional interest.
Dr. Shruti U. Bhat
Pharmaceutical Manufacturing, Continuous Improvement and Business Transformation Consultant
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