CDER Midyear Report: Sponsors Struggle With Drop In Novel Approval Rate
Executive Summary
CDER has approved only 13 novel products in the first half of 2019 while issuing at least seven such CRLs during that timeframe. The sparse approval landscape more so resembles that of 2016 compared with the banner years of 2017 and 2018.
You may also be interested in...
US FDA Ends 2019 With Second-Highest Approval Count After Second-Half Rebound
CDER's 48 novel agents, including 35 in the second half of the year, marks the second-highest novel approval count in the contemporary era.
After The Peak Of 2018’s US FDA Approval Record, 2019 Looks Like A Valley
FDA’s second half 2019 user fee calendar features almost 30 novel agents, but another record-breaking tally is out of reach.
AMAG Must Build Market For Approved Female Libido Drug To Avoid Addyi’s Fate
AMAG Pharmaceutical’s HSDD drug Vyleesi, has been approved by the FDA. But analysts warn it must build the market in women who may not be aware they have a condition if it is to fare better than Sprout’s Addyi.