CII - Orexo expects FDA filing of OX124 by mid 2022 after missing out on 'fast track' status

Orexo AB (ORXOY) announces that it expects to file a New Drug Application for its Opioid overdose rescue drug OX124 with the US Food and Drug Administration by mid-2022.OX124 is expected to follow the FDA's standard submission and review timelines, as the FDA did not grant Fast Track Designation to the product, Orexo said.Orexo had been issued an additional new US patent (Patent No. 10,874,661)  for Orexo's Zubsolv sublingual buprenorphine and naloxone tablet (CII) for the treatment of opioid use disorder, in December last year.

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Orexo expects FDA filing of OX124 by mid 2022 after missing out on 'fast track' status