FDA New Drug Approval Count May Fall Back To Earth In 2016
A repeat of FDA’s record-breaking NME approval performance from recent years looks unlikely, even though the 14 novel approvals in the first half of 2016 equals the first half total for 2015, because almost one-third fewer novel candidates have user fee goals in the second half.
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Outlining a "fairly substantial decline in the number of non-oncology NMEs approved compared to last year" plus downward trend in applications, US FDA's Jenkins underscores continued "tremendous needs" for primary care products.
After a record-setting 2015 for new drug approvals, there were not enough applications with user fee goals in 2016 to reach that level again.
The firm lowers its 2016 guidance as its European branded OTC drug and nutritional product business and its Rx topicals business appear to be major obstacles to escaping its earnings slump.