Business Standard

Friday, December 27, 2024 | 01:49 AM ISTEN Hindi

Notification Icon
userprofile IconSearch

SPARC receives Complete Response Letter (CRL) from USFDA

Image

Capital Market

For Latanoprost NDA

Sun Pharma Advanced Research Company announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response letter to its New Drug Application (NDA) for Latanoprost BAK-free eyedrops. While the FDA did not seek any additional information for supporting clinical data, it sought additional information on certain labeling and other deficiencies for processing the NDA. SPARC believes that this additional information request from the FDA can be addressed on priority.

Powered by Capital Market - Live News

Don't miss the most important news and views of the day. Get them on our Telegram channel

First Published: Dec 02 2014 | 10:59 AM IST

Explore News