FDA gives final approval to Teva for generic Actonel
JERUSALEM The Food and Drug Administration has given Teva final approval for its generic version of the Proctor & Gamble osteoporosis drug Actonel, according to Globes online.
The two companies are in litigation over the drug, which was heard in November 2006 by the U.S. District Court for the District of Delaware. The judgment has not yet been handed down.
As part of the pending litigation, Teva has to inform Proctor & Gamble within 30 days of any launch activities, but the Israeli company has not yet done so.
FluMist may be used in $2.5 billion federal program
GAITHERSBURG, Md. MedImmune’s nasal spray flu vaccine may be used in the $2.5 billion federal Vaccines for Children Program, the company said.
The Gaithersburg, Md.-based company has already begun shipping 4.5 million doses of refrigerated FluMist for the 2007-08 influenza season to customers in the United States and to U.S. military bases overseas.
In late September, the Food and Drug Administration approved expanding FluMist’s use to include children from 2 to 4 years old. The vaccine was previously approved for healthy people 5 to 49.
A Centers for Disease Control independent committee of 15 immunologists will decide whether to recommend FluMist for young children in the Vaccines for Children Program. That panel is scheduled to meet Oct. 28.
“The more we can do to vaccinate more children against this disease is very, very important,” said MedImmune spokeswoman Karen Lancaster.
Officials say 45 percent of children in the United States receive vaccines through the children’s program and the committee is the only body that determines what vaccines are included. It provides vaccines free to children without insurance and others.
The FDA approval for expanded use with younger children follows its OK in January of a refrigerated, rather than frozen, version of FluMist. While injected flu vaccines use a killed virus, FluMist uses a weakened live virus.
“It is a wonderful step in the evolution of FluMist that no longer do we have to have the frozen storage for the provider,” Lancaster said. “It opened some doors that may have been closed. With the approval of the refrigerated FluMist and expansion [to younger children], we have turned a corner with FluMist. We think there is an exciting future.”
NIH funds study on patient comliance
ATLANTA PharmaCentra, a marketing and services firm that provides customizable healthcare management programs for the pharmaceutical industry, the Rollins School of Public Health, and the Department of Ophthalmology at the School of Medicine at Emory University will conduct a study of new technology to increase patient adherence to prescribed treatment regimens.
The study, which be funded by the National Institutes of Health’s National Eye Institute will test the effectiveness of the WellTouch system, which will provide glaucoma patients with telephone and print messages to increase treatment.
“Our goal is to identify the causes of patients’ noncompliance with glaucoma treatment and then to provide an individually tailored, low cost and effective intervention to improve compliance,” said Dr. Karen Glanz, principal investigator on the project and professor at the Rollins School of Public Health.
Almost 30 percent of all patients stop taking prescribed medication within the first three months of treatment. The problem for glaucoma patients is that if they stop taking the medication, they are at a high risk to become blind.
250 people will be taking part in the study over an 18-month period.