FDA grants Mylan approval for generic Avalide application
PITTSBURGH The Food and Drug Administration has granted tentative approval to Mylan Pharmaceuticals for its application for a generic version of Sanofi Aventis’ Avalide Tablets.
The tablets, generically known as irbesartan and hydrochlorothiazide, are used to treat hypertension. The application is among the 92 that Mylan has submitted to the FDA for approval.
Avalide had U.S. sales of about $288 million for the 12 months ended March 31, according to IMS Health.
Researchers develop online tool for tracking children’s immunizations
ATLANTA Researchers at the Georgia Institute of Technology have developed an online tool to help parents and pediatricians adjust childhood immunization schedules when one or more vaccinations are missed.
When a child falls behind in the vaccination schedule, doctors must determine when it’s appropriate to give any missed vaccines or future vaccines. This usually requires the creation of a personalized catch-up schedule for each child, something that’s often done while the child sits in the treatment room. The online tool is designed to ensure that missed and future vaccines are given without violating guidelines regarding vaccines and doses.
“Physicians have been telling us for years that they needed a computerized program to tell them when to give vaccines after a child misses scheduled immunizations. Now this tool is available for health care professionals and parents to use, and they are excited to use it,” said Larry Pickering, executive director of the CDC’s Advisory Committee on Immunization Practices and a collaborator on the project.
When using the tool, a doctor or parent inputs a child’s date of birth and previous immunization dates. The program then creates a personalized schedule of the recommended dates to administer all future vaccines. It offers two options—administer the vaccines as soon as possible or administer the vaccines when recommended.
HHS awards contracts for speedy flu identification test
WASHINGTON If the world ever faced an avian influenza pandemic, how would doctors distinguish it from the seasonal flu?
Health and human services department secretary Mike Leavitt announced Thursday that the Centers for Disease Control and Prevention had awarded $12.9 million in contracts to two pharmaceutical firms for the development of tests that could distinguish the common flu from the lethal H5N1 form within three hours.
The two companies are San Diego-based Nanogen, and Gaithersburg, Md.-based Meso Scale Diagnostics, each of which received about $6.5 million for the contracts. The contracts provide funding of up to $10.4 million for Nanogen and $12.1 million for Meso Scale Diagnostics for further developments up to three years.