FDA Issues Complete Response Letter for Zynquista (sotagliflozin) - Hallo friendsLET'S HEALTHY LIFE, In the article you read this time with the title FDA Issues Complete Response Letter for Zynquista (sotagliflozin), We have prepared this article for you to read and retrieve information therein. Hopefully the contents of postings Article cough, Article diabetes, Article diseases, Article in general, Article Phytotherapy, Article skin diseases, We write this you can understand. Alright, good read.

Title : FDA Issues Complete Response Letter for Zynquista (sotagliflozin)
link : FDA Issues Complete Response Letter for Zynquista (sotagliflozin)

FDA Issues Complete Response Letter for Zynquista (sotagliflozin)

In continuation of my update on Zynquista (sotagliflozin)

 The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application for investigational Zynquista (sotagliflozin)*, a dual SGLT1 and SGLT2 inhibitor for the treatment of adults with type 1 diabetes in combination with insulin.

A CRL is a communication from the FDA that informs companies that an application cannot be approved in its present form.

Sanofi and Lexicon will work closely with the FDA to determine the appropriate next steps.

About Lexicon Pharmaceuticals

Lexicon (NASDAQ: LXRX) is a fully integrated biopharmaceutical company that is applying a unique approach to gene science based on Nobel Prize-winning technology to discover and develop precise medicines for patients with serious, chronic conditions. Through its Genome5000™ program, Lexicon scientists have studied the role and function of nearly 5,000 genes over the last 20 years and have identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. In addition to its first commercial product, XERMELO® (telotristat ethyl), Lexicon has a pipeline of promising drug candidates in clinical and pre-clinical development in diabetes and metabolism and neuropathic pain. For additional information please visit www.lexpharma.com.

*Sotagliflozin is an investigational drug and is under regulatory review by the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA). The EMA and FDA have conditionally accepted Zynquista™ as the trade name for sotagliflozin.

http://bit.ly/2PFrTNk

FDA Issues Complete Response Letter for Zynquista (sotagliflozin)

Medicinal Chemistry

Thus Article FDA Issues Complete Response Letter for Zynquista (sotagliflozin)

That's an article FDA Issues Complete Response Letter for Zynquista (sotagliflozin) This time, hopefully can give benefits to all of you. well, see you in posting other articles.

You are now reading the article FDA Issues Complete Response Letter for Zynquista (sotagliflozin) with the link address https://letslifes.blogspot.com/2019/04/fda-issues-complete-response-letter-for.html

Tweet

Subscribe to receive free email updates: