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

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

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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.

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