GlaxoSmithKline and Roche have received FDA approval for Boniva (ibandronate sodium) injection, the first intravenous treatment for postmenopausal osteoporosis. The drug provides an alternative for patients who cannot take an oral medication or are unable to remain upright for 30 to 60 minutes, a requirement when taking the tablet form of bisphosphonates. Ibandronate injection should be administered by a healthcare professional once every three months and will be available early this year.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.