FDA approves Fluarix for use in children, teens
ROCKVILLE, Md. The Food and Drug Administration announced the approval of GlaxoSmithKline’s Fluarix, a seasonal flu vaccine previously approved only for adults, for use in children and teenagers ages 3 years to 17 years. The agency said the approval was based on a clinical trial comparing Fluarix with Sanofi-Aventis’ Fluzone, a vaccine already approved for use in children, which found the two equally effective.
“This approval of an additional seasonal influenza vaccine for children provides help in protecting them against influenza,” FDA Center for Biologics Evaluation and Research acting director Karen Midthun stated. “Children are very vulnerable to the influenza virus and are more likely to be hospitalized for associated problems.”
The vaccine does not protect against the A-H1N1 swine flu, the agency said.
NCPA scholarship recipients announced
NEW ORLEANS The National Community Pharmacists Association Foundation announced recipients of scholarships for the 2009-2010 academic year Monday.
The foundation announced the recipients the NCPA’s 111th annual convention and trade exposition in New Orleans, which began Saturday and will continue until Wednesday.
“The NCPA Foundation is pleased to recognize and support this year’s student achievers,” NCPA Foundation president Sharlea Leatherwood said in a statement. “The future of community pharmacy is truly in capable hands with the leadership all of the award winners have shown.”
University of Kansas student Neil Young was named 2009 recipient of the Willard B. Simmons Sr. Memorial Scholarship, which the foundation gives to a student who has demonstrated interest in pharmacy management.
Washington State University student Andrew Helm received the J.C. and Rheba Cobb Memorial Scholarship, given to students who show interest in civic and government affairs.
University of Arizona student Lauren Bartoli received the Neil Pruitt Sr. Memorial Scholarship, given based on leadership, academic achievement and interest in entrepreneurism.
The organization also gave its 2009 Presidential Scholarships to 18 students, selected on the basis of academic achievement, leadership, interest in community pharmacy and extracurricular accomplishments. The recipients are:
- Richard Boyd, Ohio Northern University
- Whitney Brace, University of Texas at Austin
- Manpreet Chahal, Washington State University
- Getrude Chimhungwe, University of Buffalo
- Jinal Desai, University of Southern Nevada-South Jordan
- Stephanie Field, West Virginia University
- Paul Frazier, University of Southern Nevada-South Jordan
- Scott Halvorson, University of Missouri-Kansas City
- Tanaz Kohan, University of Southern California
- Lauren Marston, Virginia Commonwealth University
- Chibuzor Okoro, Howard University
- Brittany Provence, Drake University
- Summer Schroeder, University of New Mexico
- Regina Scott, University of New Mexico
- Cassandra Shields, University of Missouri-Kansas City
- Renee Tobey, University of Oklahoma Health Science Center
- Kendra VanGrinsven, University of Wyoming
- Hillary Volsteadt, Mercer University
A further seven Partners in Pharmacy Scholarships went to students who had demonstrated academic achievement, community service and interest in independent community pharmacy. The recipients of those scholarships are:
- Lucas Bozick, Texas Tech Health Science Center
- Jennifer Evans, University of Southern Nevada-South Jordan
- Sarah Griffin, University of Arkansas
- Julie Keeton, University of Kansas
- Staci Kurmel, Incarnate Word Feik School of Pharmacy
- Jennifer Nemnich, University of Kansas
- Thurston, Washington State University
FDA declines approval for Rituxan, methotrexate combination
SOUTH SAN FRANCISCO, Calif. The Food and Drug Administration declined to approve an additional use of a rheumatoid arthritis drug while approving an update to its prescribing information, the drug’s manufacturers announced Monday.
Roche subsidiary Genentech and Biogen Idec said the FDA had given them a complete response letter for their approval application seeking additional use of the drug Rituxan (rituximab), for combining Rituxan with the generic drug methotrexate in patients with moderate to severe rheumatoid arthritis who no longer respond to treatment with disease-modifying antirheumatic drugs such as methotrexate alone.
At the same time, the FDA approved an update to Rituxan’s labeling to show how late-stage rheumatoid arthritis patients can be treated again with Rituxan if they have not responded well enough to drugs called tumor necrosis factor-antagonist therapies.
The FDA declined the approval application for Rituxan combined with methotrexate due to the rare risk of patients developing progressive multifocal leukoencephalopathy, a usually deadly brain infection caused by the JC virus. PML is rare in patients taking Rituxan, but Genentech also withdrew the psoriasis drug Raptiva (efalizumab) earlier this year after determining that the benefits of the drug did not outweigh the risks of patients developing PML.