The delay caused by receiving a complete response letter in the end enabled Shire PLC'sXiidra (lifitegrast) to get the best possible indication – to treat both the signs and symptoms of dry eye disease.
The drug cleared FDA July 11 as the first drug for that indication, despite an initial submission with mixed data and a complete response letter in October 2015. At that...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?