FDA OKs storage option for Kogenate FS
WAYNE, N.J. — The Food and Drug Administration has approved a new storage option for a hemophilia A treatment made by Bayer HealthCare Pharmaceuticals, the drug maker said.
Bayer announced that Kogenate FS (antihemophilic factor [recombinant]) now can be stored at room temperature, up to 77 degrees, for up to one year. Previously, it could be stored at room temperature for three months, and most Factor VIII products must be stored in a refrigerator.
Bayer said the new storage option would give patients more flexibility for storing their medication while freeing up space in the refrigerator and eliminating the need for a separate “factor fridge.”
“As convenience with medication is important to people with hemophilia A, we’re pleased to offer a new storage temperature option, which complements other convenience factors, including Grab and Go packaging with Bio-Set, a compact and complete reconstitution system for Kogenate FS,” Bayer HealthCare Pharmaceuticals VP and general manager for hematology Paul Bedard said. “This new option demonstrates Bayer’s ongoing commitment to the hemophilia A community.”
PCMA: Mail-service pharmacies drive generic utilization
WASHINGTON — An organization representing the nation’s pharmacy benefit managers said that mail-service pharmacies are increasing the use of generic medications.
The Pharmaceutical Care Management Association issued a statement on Tuesday claiming that mail-service pharmacies leverage generic opportunities for savings, adding that there is no marked difference in the generic dispensing rate between mail-service pharmacy and retail pharmacy.
"The Federal Trade Commission and Harvard University both found that mail-service pharmacies practice generic substitution — substituting equivalent generics for brands whenever possible — more frequently than retail pharmacies," PCMA said. "Generic prescriptions are also less costly when obtained through mail-service pharmacies, according to research from the FTC and the Government Accountability Office."
Taro resolves FDA warning letter
HAWTHORNE, N.Y. — Taro said that the Food and Drug Administration has declared the drug maker’s manufacturing facility in Canada as having acceptable regulatory status.
The drug maker said it diligently worked to resolve issues noted in an FDA warning letter dated Feb. 5, 2009. The regulatory agency reinspected the manufacturing facility last February.
"We are dedicated to developing and manufacturing quality products for our customers while meeting and exceeding all good manufacturing practices standards set by the FDA and Health Canada," said James Kedrowski, interim CEO for Taro.