logo
Plus   Neg
Share
Email

Sanofi: FDA Issues CRL For Zynquista

Sanofi (SNYNF,SNY) said that the U.S. Food and Drug Administration 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 step.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Panera Bread Co. is launching a new subscription program that will allow customers to drink unlimited coffee and tea. The new program of $8.99 per month launches Thursday and covers hot coffee, iced coffee and hot tea. With the introduction of the subscription, Panera becomes the first national restaurant company to offer unlimited hot drip coffee, iced coffee and hot tea for $8.99 per month. Best Buy Co. Inc. (BBY) Thursday reported a fourth-quarter profit that increased 1.4 percent from last year, while, J. C. Penney Co.'s (JCP) quarterly profit dropped 64 percent. However, the results of the companies topped analysts' estimates. Safavieh LLC recalled about 760 units of Aura and Silas 3-Drawer Chests for possible serious tip-over and entrapment hazards that can result in death or injuries to children, the U.S. Consumer Product Safety Commission said in a statement. The company said the chests are unstable if they are not anchored to the wall.
Follow RTT
>