CSL News: ARS Pharmaceuticals Submits Response for neffy® (epinephrine nasal spray) Marketing Authorization - 30th Apr 2024, 11:01pm

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CHMP opinion on neffy Marketing Authorization Application anticipated in the second quarter of 2024

Response addresses all issuespreviously identified by CHMP, and includes results from a repeat dose PK/PD study of neffy under NAC conditions and updated testing concerning nitrosamine levels

Exclusive licensing deal for Australia and New Zealand with CSL Seqirus; CSL Seqirus will be responsible for applying for regulatory approval, reimbursement and commercialization of neffy. ARS Pharmaceutica...

>>> Read more: ARS Pharmaceuticals Submits Response for neffy® (epinephrine nasal spray) Marketing Authorization Application to EMA’s CHMP and Enters License Agreement with CSL Seqirus for Commercialization of neffy in Australia and New Zealand
 
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