Brief: Mithra Pharmaceuticals: Mayne Pharma Received A CRL From The FDA Regarding Myring

Mithra Pharmaceuticals SA

06/10/2021 16:55

Oct 6 (Reuters) - Mithra Pharmaceuticals SA  MITRA.BR :
    * MITHRA PHARMACEUTICALS PROVIDES FDA UPDATE ON MYRING®
    * ANNOUNCES THAT ITS US COMMERCIAL PARTNER MAYNE PHARMA 
RECEIVED
A (CRL) FROM THE US FOOD AND DRUG ADMINISTRATION  (FDA) IN
RELATION TO THE ABBREVIATED NEW DRUG APPLICATION (ANDA) FOR
MYRING
    * MAYNE PHARMA IS WORKING CLOSELY WITH MITHRA AND THE FDA TO
ADDRESS THE FEW REMAINING  QUESTIONS RAISED IN THE CRL BEFORE
YEAR-END
    * IN THE LETTER, MAYNE PHARMA HAS BEEN REQUESTED TO PROVIDE
ADDITIONAL DATA ON COMPATIBILITY.
    * ALL OTHER  TOPICS, IN PARTICULAR THE MANUFACTURING PROCESS
BY
THE MITHRA CDMO, DID NOT RAISE ANY SUPPLEMENTARY  QUESTIONS

Source text for Eikon:  ID:nNDL59pZMN 
Further company coverage:  MITRA.BR 

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