Optimer Pharmaceuticals has announced the approval of Dificid (fidaxomicin) Tablets by the Australian regulatory body, the Therapeutic Goods Administration.
Specialised Therapeutics Australia that has license to fidaxomicin in Australia and New Zealand will make the product available in Australia from 14 May 2013.
Optimer CEO and board chairman Dr. Hank McKinnell said Clostridium difficile infections represent a challenge to treating physicians across the world.
"With the recent approval in Australia, and the earlier approvals in the U.S., Europe and Canada, fidaxomicin is now approved by four regulatory agencies, broadening access to patients in need across the globe," McKinnell added.
The data from two Phase 3 trials designed to ensure the safety and efficacy of 200mg of Dificid twice a day compared to 125mg of oral vancomycin four times a day for 10 days in subjects with CDI, supported the Australian approval.