FDA accepts filing for CDI treatment
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.
“In phase-3 clinical trials, fidaxomicin not only showed a high clinical cure rate, but also demonstrated a statistically significant improvement in reducing recurrences, one of the major problems in the current management of CDI,” Optimer president and CEO Pedro Lichtinger said.
Viibryd gets FDA approval
SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating major depressive disorder, the agency said Friday.
The FDA announced the approval of Viibryd (vilazodone hydrochloride), made by New Haven, Conn.-based PGxHealth.
“Major depressive disorder is disabling and prevents a person from functioning normally,” FDA Division of Psychiatry Products director Thomas Laughren said. “Medications affect everyone differently, so it’s important to have a variety of treatment options available to patients who suffer from depression.”
PIPCo joins NCPA
ALEXANDRIA, Va. — Shortly after the Pharmacy Providers of Oklahoma joined a group representing the nation’s independent community pharmacies and their patients, another organization also has signed up.
The National Community Pharmacists Association said Monday that the Partners in Pharmacy Cooperative have signed up for NCPA membership. PIPCo is an independent pharmacy cooperative owned and managed by its independent community pharmacy members in the north-central United States.
“PIPCo is dedicated to the support of independent pharmacies and keeping them profitable in a competitive marketplace,” said Robert Greenwood, NCPA president. “We at NCPA share that same dedication to independent pharmacy’s future and ability to continue providing expert medication counseling and other cost-saving services to patients. While PIPCo’s leadership and many of its members have long been a part of NCPA, we are glad to now have all PIPCo members join us.”