Galenicum announces successful bioequivalence study for Dutasteride

December 27, 2012

Galenicum has confirmed that Dutasteride 0.5 mg soft gel capsules used for the treatment of benign prostatic hyperplasia (BPH) have been given proof of bioequivalence to the commercialized Avodart 0.5 mg capsules. The registration is expected to start by January 2013.

It is the latest generic drug developed by Galenicum to successfully gain bioequivalence this year, following the positive bioequivalence of the non-steroidal anti-inflammatory Dexketoprofen in March, and Cilostazol, the medication used for the treatment of peripheral vascular disease, in May. Both products have been submitted to several European countries over the past year.