US FDA Approval of Farxiga (dapagliflozin)

RNS Number : 2589X

AstraZeneca PLC

09 January 2014

 



ASTRAZENECA AND BRISTOL-MYERS SQUIBB ANNOUNCE
US FDA APPROVAL OF FARXIGA™ (DAPAGLIFLOZIN)

AstraZeneca and Bristol-Myers Squibb Company today announced the US Food and Drug Administration (FDA) approved FARXIGA™ (dapagliflozin).

See http://packageinserts.bms.com/pi/pi_farxiga.pdf for US Full Prescribing Information for FARXIGA.

The companies will provide additional details regarding the approval in a press release to follow.

About the AstraZeneca/Bristol-Myers Squibb Diabetes Alliance

Dedicated to addressing the global burden of diabetes by advancing individualised patient care, AstraZeneca and Bristol-Myers Squibb are working in collaboration to develop and commercialise a versatile portfolio of innovative treatment options for diabetes and related metabolic disorders that aim to provide treatment effects beyond glucose control. Find out more about the Alliance and our commitment to meeting the needs of health care professionals and people with diabetes at www.astrazeneca.com or www.bms.com.  

On 19 December 2013 AstraZeneca and Bristol-Myers Squibb announced an agreement under which AstraZeneca will acquire the entirety of Bristol-Myers Squibb's interests in the companies' diabetes alliance to consolidate worldwide ownership of the diabetes business within AstraZeneca.  The closing of the transactions contemplated by the agreement is subject to customary terms and conditions, and is expected to occur during the first quarter of 2014.  

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com. 

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.

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9 January 2014

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