Eli Lilly sees favorable signs from FDA for approval of long-acting Zyprexa
INDIANAPOLIS Eli Lilly seems to believe that a long-acting form of its best selling drug, Zyprexa, which is used to treat schizophrenia, will likely become in the U.S. in the “near future,” based on favorable signs from the Food and Drug Administration, according to Reuters.
Lilly chief executive John Lechleiter said the company’s optimism is based on recent meetings between itself and the FDA, which in February had rejected the injectable form of Zyprexa. In issuing its “not approvable” letter, the FDA had said it needed more information to better understand the risk and underlying cause of excessive sedation seen in about 1 percent of patients given the injectable formulation in clinical trials.
Based on recent meetings with FDA officials, Lechleiter said Lilly thinks it can satisfy the agency’s concerns without conducting new clinical trials of the long-acting formulation and is hopeful it will soon become available to patients.
The basic form of Zyprexa had 2007 sales of $4.8 billion, but it will lose U.S. patent protection in 2011.
Bystolic fulfills pharmacists’ desire for a new beta-blocker
NEW YORK Forest Laboratories and Mylan’s new, once-daily hypertension drug Bystolic now is available in pharmacies nationwide.
A recent survey showed that out of 20,000 retail pharmacists, 78 percent felt there was a need for a beta-blocker with an improved tolerability profile.
More than 2,000 people received Bystolic (nebivolol) during clinical trials. The drug’s efficacy was similar to that of other approved beta-blockers, the FDA said. The most common reported side effects were headache, fatigue, dizziness and diarrhea.
Hypertension affects about 72 million adults in America.
Tenn. pharmacy school receives $600,000 grant
NASHVILLE, Tenn. Lipscomb University has received a $600,000 grant from The Memorial Foundation to support the school’s new $10.1 million pharmacy school, which will receive its first class in August, according to published reports. The Lipscomb College of Pharmacy has accepted 75 students in its first class.
The money will be used to build three patient support laboratories where students will learn to compound and prepare drugs, carry out experiments and examine and assess patients.
The school will be located in the Burton Health Sciences Center. In honor of the foundation’s grant the labs will be named The Memorial Foundation Pharmacy Practice Center.
“We believe it is a good investment for the community and for those students who want to prepare for a career in pharmacy,” said J.D. Elliott, president of The Memorial Foundation.