Brief: Oncopeptides Says FDA Requests For Withdrawal Of Authorization For Pepaxto

Oncopeptides AB

07/12/2022 13:05

Dec 7 (Reuters) - Oncopeptides AB  ONCO.ST :
    * ONCOPEPTIDES PROVIDES UPDATE ON PEPAXTO US MARKETING
AUTHORIZATION
    * ANNOUNCES THAT US FOOD AND DRUG ADMINISTRATION, FDA, HAS
REQUESTED A WITHDRAWAL OF US MARKETING AUTHORIZATION FOR
PEPAXTO(®) (MELPHALAN FLUFENAMIDE, ALSO CALLED MELFLUFEN)
    * REQUEST IS BASED ON OUTCOME OF CONFIRMATORY PHASE 3 OCEAN
STUDY

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