ASTRAZENECA AB — Xigduo Xr FDA Summary Review (NDA/BLA 205649, 2015)

AstraZeneca PLC · 2015 · FDA Summary Review (Drugs@FDA) · company profile →

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This summary review covers NDA 205649 for AstraZeneca's Xigduo XR (dapagliflozin/metformin HCl), a fixed-dose combination for Type 2 Diabetes Mellitus. It details the drug's chemistry, manufacturing, controls, nonclinical pharmacology/toxicology, and clinical pharmacology. Key findings indicate Xigduo XR's superiority over individual components in improving HbA1c, fasting plasma glucose, and body weight, alongside a discussion of its safety profile and adverse events.

Key findings — cited to the page

Plasma elimination half-life of metformin	6.2 hours	metformin · p.7
Approval status of Xigduo	not approved	Xigduo · any country · p.3
Shelf-life recommendation for FDC	24 months	Xigduo XR · p.5
NDA Number	205649	Xigduo XR · p.3
NOAEL for dapagliflozin and metformin combination	52 x	· p.5
Absolute oral bioavailability of dapagliflozin	78 %	dapagliflozin · p.7
High-fat meal effect on dapagliflozin Cmax	50 %	dapagliflozin · p.7
Dapagliflozin protein binding	91 %	dapagliflozin · p.7
Mean plasma terminal half-life of dapagliflozin	12.9 hours	dapagliflozin · p.7
Absolute bioavailability of metformin	50-60 %	metformin · p.7
Food effect on metformin absorption	50 %	metformin · p.7
Blood elimination half-life of metformin	17.6 hours	metformin · p.7

Source: AstraZeneca PLC ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →