Keeping Track: Approval Of First Intranasal Naloxone Copycat Highlights Otherwise Generic Week

Apr 19 2019

• By Michael Cipriano and Brenda Sandburg

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The latest drug development news and highlights from our US FDA Performance Tracker.

Keeping Track Feature image — Viela Bio's inebilizumab for NMOSD and Genfit's elafibranor for PBC win breakthrough designations; Novartis uses priority review voucher for wet AMD treatment brolucizumab.

It's only fitting that a relatively slow and otherwise generic week of US biopharma news was highlighted by FDA's first full approval of a copycat intranasal naloxone product to counter opioid overdose. The honor went to Teva Pharmaceutical Industries Ltd., which previously received a tentative approval for its generic Narcan (naloxone hydrochloride) nasal spray product in June 2018.

Viela Bio's inebilizumab and Genfit SA's elafibranor each received breakthrough therapy designations (BTDs), intensifying development competition in their...

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