Bristol-Myers Squibb seeks additional approval for Orencia
PRINCETON, N.J. — The Food and Drug Administration has accepted for review a supplemental approval application for an arthritis drug made by Bristol-Myers Squibb, the drug maker said Monday.
Bristol is seeking approval for Orencia (abatacept) injected into the skin as a treatment for adults with moderate to severe rheumatoid arthritis. The drug already is approved for intravenous injection.
The company filed the application in October after a phase-3 trial program of 1,847 patients showed that patients receiving weekly skin injections of the drug showed about the same degree of improvement as those receiving the drug by IV.
Under PEPFAR, Matrix gets tentative approval for Ziagen generic
PITTSBURGH — The Food and Drug Administration has given tentative approval to a generic drug for HIV/AIDS made by Mylan subsidiary Matrix Labs for distribution in developing countries under the President’s Emergency Plan for AIDS Relief, Mylan said Tuesday.
The tentative approval under PEPFAR covers Matrix’s abacavir sulfate tablets in the 60-mg strength. The drug is a generic version of ViiV Healthcare’s Ziagen, and is used to treat the disease in children.
“This approval is particularly important because it adds to the available treatment options for children who are living with HIV/AIDS in developing countries,” Mylan president Heather Bresch said. “The addition of abacavir to Mylan and Matrix’s HIV/AIDS antiretroviral franchise is a critical next step in helping to extend and improve the quality of life of people living with HIV/AIDS, and to continue to expand access to high-quality, affordable ARVs.”
Cardinal Health extends distribution agreement with Walgreens
DUBLIN, Ohio — Cardinal Health on Tuesday announced the extension of its distribution agreement to supply pharmaceuticals to Walgreens’ national network of retail pharmacies.
The agreement will prolong into 2013. Additional terms of the deal were not disclosed.
“Walgreens is a valued partner for Cardinal Health, and we are proud to continue our long-standing relationship,” said George Barrett, Cardinal Health chairman and CEO. “The new agreement builds on the fundamentals of our existing relationship, and the terms were factored into the fiscal 2011 guidance we provided in October.”