Sandoz looks to market generic Vyvanse
DUBLIN — Sandoz is looking to market a generic version of a Shire drug for treating attention deficit hyperactivity disorder.
Shire said Thursday that it received a notice letter from Sandoz, the generics division of Swiss drug maker Novartis, that the latter had filed a regulatory approval application with the Food and Drug Administration for a generic version of Vyvanse (lisdexamfetamine dimesylate). The application contained a Paragraph IV certification, a legal assertion that the patents covering Vyvanse — all of which expire in 2023, according to the FDA Orange Book — are invalid, unenforceable or won’t be infringed.
Under the Hatch-Waxman Act of 1984, Shire has 45 days in which to review Sandoz’s letter and determine if it will file a patent infringement suit, which would result in the FDA placing a 30-month stay of approval on the generic. In many cases of generic drug companies challenging branded drug patents, however, the generic and branded company will reach a settlement that allows the generic launch to occur before the patents expire.
Medco, Verizon developed mobile app
FRANKLIN LAKES, N.J. — Telecommunications provider Verizon Wireless and pharmacy benefit manager Medco Health Solutions have unveiled a mobile application that the companies said would allow patients and their doctors to instantly find the lowest-cost prescription drugs to meet their health needs and identify potentially harmful drug interactions.
The new Medco Pharmacy mobile app for Verizon Wireless Android and BlackBerry smartphones, is available for download from Verizon. The app provides information about out-of-pocket costs for any prescription drug and lower-cost options specific to a patient’s drug plan, as well as drug-interaction alerts based on the patient’s prescription history, including for patients treated by several doctors or who fill prescriptions at multiple pharmacies.
The app consists of three features: My Rx Choices, which delivers on-demand, personalized out-of-pocket costs, interactions and other information for any prescription drug; My Medicine Cabinet, which allows patients to view the medications they’re on, including prescription and over-the-counter drugs, and set reminders for themselves; and Prescription ID Card, which allows convenient access to a member’s prescription drug card.
“Wireless devices are a part of the lifestyle as we know it today, and millions of people rely on their BlackBerry and Android smartphones for instant information,” Verizon Wireless VP sales Mike Ross said. “Reliability is paramount to not only medical formation, but for a network too. Our combined technologies will give users a powerful tool that can help them manage their medical care.”
Pradaxa granted preferred formulary status through AARP’s Prescription Solutions
RIDGEFIELD, Conn. — A drug for cardiovascular disease made by Boehringer Ingelheim has received preferred formulary status with AARP’s Medicare Part D plans, the drug maker said Thursday.
BI announced that Pradaxa (dabigatran etexilate mesylate) received preferred Tier 2 formulary status through AARP’s pharmacy benefit manager, Prescription Solutions. The Food and Drug Administration approved Pradaxa in October 2010 to reduce the risk of stroke and embolism in patients with nonvalvular atrial fibrillation.
“The addition of Pradaxa to the nation’s largest Part D plans helps ensure that many more NVAF patients have access to this important medication, which in a clinical study has been shown to significantly reduce the risk of stroke compared to warfarin,” Boehringer Ingelheim Pharmaceuticals VP cardiovascular and metabolic disorders marketing Wa’el Hashad said. “Pradaxa is now on formulary with AARP, Medco, Express Scripts and several more of the nation’s largest managed care providers.”