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FDA accepts Bayer’s sBLA for myBETAapp and BETACONNECT Navigator

Thursday, December 15, 2016

Bayer has announced that the FDA has accepted the filing of a supplemental Biologics License Application (sBLA) for myBETAapp and the BETACONNECTNavigator. MyBETAapp is intended for patients taking BETASERON (interferon beta-1b), to help them record their treatment information such as drug injections and injection sites. The BETACONNECT Navigator is a tool that enables healthcare professionals the ability to review injection history for their patients.

“Mobile health technology is a growing area in healthcare communication today,” said Mark Rametta, D.O, FACOI, FACP, Bayer’s medical director for Neurology. “The filing of myBETAapp and the BETACONNECT Navigator supports our continued commitment to meeting the needs of patients taking BETASERON to treat their relapsing forms of multiple sclerosis (MS). We have proudly supported the MS community for more than 20 years.” 

BETASERON (interferon beta-1b) is a prescription medicine used to reduce the number of relapses in people with relapsing forms of multiple sclerosis (MS). This includes people who have had their first symptoms of multiple sclerosis and have an MRI consistent with multiple sclerosis. BETASERON will not cure MS but may decrease the number of flare-ups of the disease.

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