Ozempic®. Novo Nordisk A/S's Ozempic (semaglutide) is a once-weekly injection to improve glycemic control in adults with type 2 diabetes.

Avastin®. Genentech, Inc.'s Avastin® (bevacizumab) received full approval to treat adults with glioblastoma that has progressed following prior therapy. Avastin was previously granted provisional approval for this indication under the FDA's accelerated approval program.

Ogivri™. Mylan GmbH's Ogivri (trastuzumab-dkst) was approved as a biosimilar to Genentech, Inc.'s Herceptin® (trastuzumab). Ogivri treats patients with breast or metastatic stomach cancer whose tumors overexpress the HER2 gene. This is the second FDA-approved biosimilar to treat cancer and the first to treat breast cancer or stomach cancer (see Legal Update, Recent Notable FDA Approvals, September 20, 2017).

Sublocade™. Indivior Inc.'s Sublocade (buprenorphine) is the first injectable depot formulation of buprenorphine, a once-monthly medication-assisted treatment for moderate-to-severe opioid use disorder. Prior to use, patients must have been on a stable dose of buprenorphine treatment for a minimum of seven days. The FDA simultaneously released guidelines for approval of depot formulations of buprenorphine (see Legal Update, FDA Announces New Actions to Encourage Medication-Assisted Therapy for Opioid Abuse).The FDA previously granted Sublocade priority review and fast-track designations.

FoundationOne® CDx. Foundation Medicine, Inc.'s CDx (F1CDx) is the first next-generation sequencing-based in vitro diagnostic (IVD) test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type. The test can be used as a companion diagnostic for 15 FDA-approved treatments. Most companion diagnostics match one test to one drug. The Centers for Medicare & Medicaid Services (CMS) simultaneously proposed nationwide coverage of the F1CDx. This is the second IVD to be approved and covered under the Parallel Review Program. The FDA-CMS Parallel Review Program is a voluntary program where the agencies concurrently review medical devices to help reduce the time between the FDA's approval of a device and Medicare coverage. The FDA previously granted CDx breakthrough-device designation.