04.03.2015, 22:47
AstraZeneca to participate in US FDA Endocrinologic and Metabolic Drugs Advisory Committee
OREANDA-NEWS. AstraZeneca announced it will participate in the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee meeting on 14 April 2015 to discuss the results of the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR) trial for ONGLYZA® (saxagliptin) and Kombiglyze® XR (saxagliptin and metformin HCI extended-release).
The topic of the Advisory Committee is based on an ongoing review of a previously submitted supplemental New Drug Application to the FDA for ONGLYZA and Kombiglyze XR.
AstraZeneca welcomes the opportunity to discuss the SAVOR cardiovascular outcomes data with the Advisory Committee.
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