Brief: Hyloris Announces Potential US Maxigesic Registration Date

Hyloris Pharmaceuticals SA

02/05/2023 06:08

May 2 (Reuters) - Hyloris Pharmaceuticals SA  HYL.BR :
    * REG-HYLORIS ANNOUNCES POTENTIAL REGISTRATION DATE FOR
MAXIGESIC®
IV IN THE US
    * PDUFA GOAL DATE SET FOR 17 OCTOBER 2023 BY U.S. FOOD &
DRUG
ADMINISTRATION
    * EXCLUSIVE COMMERCIAL PARTNER FOR MAXIGESIC® IV IN U.S. IS
HIKMA
PHARMACEUTICALS, A LEADING SUPPLIER OF COMPLEX, INJECTABLE
HOSPITAL PRODUCTS
    * PRESCRIPTION DRUG USER FEE ACT (PDUFA) GOAL DATE OF 17
OCTOBER
2023 SET BY FDA CONFIRMS ANTICIPATED REVIEW PERIOD OF 6 MONTHS,
AND A POTENTIAL REGISTRATION OF MAXIGESIC® IV FOR US MARKET
BEFORE END OF 2023
    * UNDER THE TERMS OF THE DEVELOPMENT COLLABORATION AGREEMENT
BETWEEN HYLORIS AND AFT, HYLORIS IS ELIGIBLE TO RECEIVE A SHARE
ON ANY PRODUCT-RELATED REVENUES, SUCH AS LICENSE FEES,
ROYALTIES, MILESTONE PAYMENTS, RECEIVED BY AFT

Source text for Eikon:  ID:nGNExxPKv 
Further company coverage:  HYL.BR 

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