FDA turns down two Novo Nordisk insulin products
BAGSVÆRD, Denmark — The Food and Drug Administration declined to approve two insulin products made by Danish drug maker Novo Nordisk, the company said Sunday.
Novo Nordisk said it received complete response letters from the FDA for Tresiba (insulin degludec) and Ryzodeg (insulin degludec and insulin aspart). The FDA issues a complete response letter when it has finished reviewing an application for a drug, but determines that the application can’t be approved in its current form.
Reuters reported Monday the FDA had requested additional clinical trial data before it would consider approving Tresiba and Ryzodeg, but the company would not able able to provide the data in 2013 or 2014.
Shire to pay Impax $48 million in authorized generic Adderall XR case
HAYWARD, Calif. — Generic drug maker Impax Labs has settled with Shire Labs over an authorized generic version of a Shire drug for treating attention deficit hyperactivity disorder, Impax said.
Impax began selling its authorized generic version of Adderall XR (dextroamphetamine and amphetamine) in October 2009 under contract with Shire, but the generic drug maker filed suit against Shire in November 2010 for breach of contract and other related claims, alleging that Shire had failed to fill Impax’s orders for the drug. Shire responded with a counterclaim concerning Impax’s ordering practices under the agreement.
An authorized generic is a branded drug marketed under its generic name at a reduced price, usually under a contract between the branded drug’s manufacturer and a third-party company.
Under the settlement, Impax’s claims and Shire’s counterclaims will be dismissed, and Shire will make a one-time cash payment to Impax of $48 million. Impax will still have the right to sell its products on hand or owed to it under the agreement after the supply agreement expires, in September 2014.
NACDS Foundation announces Pharmacy Student Scholarship recipients
ARLINGTON, Va. — The National Association of Chain Drug Stores Foundation announced on Monday the recipients of the annual Pharmacy Student Scholarship Awards.
The NACDS Foundation Pharmacy Student Scholarship Program identifies and recognizes the next generation of pharmacy leaders during their pursuit of academic success and educational goals. The NACDS Foundation awarded scholarships totaling $30,000 to six pharmacy students.
The six NACDS Foundation Pharmacy Student Scholarship Awards were chosen to receive named scholarships that honor distinguished pharmacy leaders and companies that share the NACDS Foundation’s commitment to education, research and charitable work. The recipients are as follows:
Mark Schiffmann of the University of Minnesota College of Pharmacy and Emily Swayka of Roosevelt University College of Pharmacy received the Leonard J. DeMino Pharmacy Student Scholarships.
Laura Vollmer of Drake University College of Pharmacy & Health Sciences and Joshua Prostek of the University of Wisconsin-Madison School of Pharmacy received the Taro Research Foundation Scholarships.
Delaram Bahmandar of Roseman University of Health Sciences College of Pharmacy and Ashle Kappenman of the University of Iowa College of Pharmacy received the Teva Pharmaceuticals Robert J. Bolger Scholarships.
“These students represent the future of pharmacy, and we applaud them for their academic accomplishments. Each exemplifies one of the key missions of the NACDS Foundation in supporting continuing education programs that focus on patient-centered care in the community pharmacy setting,” stated NACDS Foundation president Kathleen Jaeger. “We are delighted to honor these exceptional students with scholarships to assist them in continuing their pharmacy education."