Content about Optimer Pharmaceuticals

May 31, 2011
Dificid gets nod as CDAD treatment

The Food and Drug Administration has approved a treatment for diarrhea caused by a bacterial infection.

SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for diarrhea caused by a bacterial infection.

The agency announced the approval of Optimer Pharmaceuticals’ Dificid (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhea, also known as CDAD.

January 24, 2011
FDA accepts filing for CDI treatment

The Food and Drug Administration has accepted a regulatory filing from Optimer Pharmaceuticals for a drug to treat bacterial infections.

SAN DIEGO — The Food and Drug Administration has accepted a regulatory filing from Optimer Pharmaceuticals for a drug to treat bacterial infections.

Optimer announced Monday the FDA’s acceptance of its approval application for fidaxomicin for treating clostridium difficile infection, or CDI. CDI is a colon infection that is a particular problem in hospitals, long-term care centers and in the broader community. It is estimated to affect more than 700,000 people per year. The agency has granted the application priority review and expects to finish its review by May 30.