FDA approves Mylan’s generic epilepsy drug
PITTSBURGH The Food and Drug Administration has approved Mylan’s generic version of GlaxoSmithKline’s epilepsy drug Lamictal, Mylan announced Wednesday.
The drug, known generically as lamotrigine, is also used to treat bipolar disorder. Mylan will sell the drug in the 25 mg, 100 mg, 150 mg and 200 mg strengths. The FDA also approved Genpharm?s application for a chewable generic version of Lamictal.
The branded version of the drug had sales of about $91 million in the year ending Sept. 30, according to IMS Health.
Sage launches new version of Intergy
TAMPA, Fla. Software maker Sage announced Monday that it launched the latest version of its Intergy electronic medical records platform.
The company said the updates in version 5.5 are designed to expand interoperability with other systems and devices, address the needs of obstetrics, pediatrics and cardiology and streamline billing and collections.
Specific updates to the software include expanded e-prescribing capabilities, including full integration with pharmacy benefit managers through RxHub; cardiac device integration to allow doctors to pull data directly from devices to electronic health records; predictive orders management that analyzes the way individual physicians practice medicine to deliver decision support and workflow management specific to them; and increased operability for pediatric practices.
“The challenges our customers face in this healthcare environment are significant,” Sage SVP sales and marketing Sharon Howard said in a statement. “Declining reimbursements and increasing regulations put increased pressures on practices every year.”
PhRMA urges selection of new FDA commissioner
WASHINGTON The CEO of the Pharmaceutical Research and Manufactureres of America issued a statement Tuesday encouraging the selection and confirmation of a new commissioner for the Food and Drug Administration.
“Dr. Frank Torti was a wise choice to lead the Food and Drug Administration on an interim basis, and PhRMA applauded this selection,” PhRMA CEO Billy Tauzin said. “Torti shares PhRMA’s patient-centric approach and brings a strong commitment to science-based decision-making. We look forward to president Barack Obama?s expeditious selection of a full-time leader for the FDA.”
Tauzin said the ideal candidate should have strong managerial skills essential to directing science-based activities at an expanded FDA.
“These skills are particularly important to an agency that is striving to implement groundbreaking reforms to better position itself to tackle future challenges, including modernizing FDA methods for evaluating safety and efficacy throughout a product?s life cycle,” he said.