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Approvals for Novo Nordisk, Alembic; designations for AstraZeneca, Novavax

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Approvals for Novo Nordisk, Alembic; designations for AstraZeneca, Novavax

Approvals and designations made by the U.S. Food and Drug Administration for the week ended Jan. 17.


*Novo Nordisk A/S' Ozempic for expanded use in reducing the risk of major adverse cardiovascular events — including cardiovascular death, nonfatal heart attack or nonfatal stroke — in adults with type 2 diabetes and established cardiovascular disease.

*Alembic Pharmaceuticals Ltd.'s generic version of diabetes drug Jardiance, co-marketed by Eli Lilly and Co.and Boehringer Ingelheim GmbH. Alembic's drug is the first generic of Jardiance to be available in the U.S. after receiving tentative approval.

SNL ImageFDA headquarters in Silver Spring, Md.
Source: Associated Press

Priority review

*AstraZeneca PLC and Merck & Co. Inc.'s Lynparza as a maintenance therapy for patients with advanced ovarian cancer who are in complete or partial response to initial treatment with Roche Holding AG's Avastin, or bevacizumab, plus platinum-based chemotherapy.

*Clovis Oncology Inc.'s Rubraca as a stand-alone therapy for adult patients with castrate-resistant prostate cancer that came back and had spread to other parts of the body. The patients also have a mutation in their BRCA1 and BRCA2 genes.

Fast track

*Novavax Inc.'s NanoFlu combined with its immune response enhancer Matrix-M for seasonal viral respiratory infections in senior adults.

*Arena Pharmaceuticals Inc.'s APD418 for decompensated heart failure.

Other designations

* Rare pediatric disease designation, for Fortress Biotech Inc.'s CUTX-101, for Menkes disease.