FDA extends regulatory review period for IDegLira by three months
(Thomson Reuters ONE) -
Bagsværd, Denmark, 2 September 2016 - Novo Nordisk today announced that the US
Food and Drug Administration (FDA) has extended the regulatory review period for
IDegLira, the fixed-ratio combination of insulin degludec and liraglutide in
adults with type 2 diabetes.
The FDA informed Novo Nordisk that a three-month extension was required in order
to complete its review of the new drug application (NDA) for IDegLira.
Novo Nordisk submitted the NDA to the FDA in September 2015, and with the
extension of the review the action date is now expected in December 2016.
Further information
Media:
Katrine Sperling +45 3079 6718 krsp(at)novonordisk.com
Ken Inchausti (US) +1 609 786 8316 kiau(at)novonordisk.com
Investors:
Peter Hugreffe Ankersen +45 3075 9085 phak(at)novonordisk.com
Melanie Raouzeos +45 3075 3479 mrz(at)novonordisk.com
Hanna Ögren +45 3079 8519 haoe(at)novonordisk.com
Kasper Veje (US) +1 609 235 8567 kpvj(at)novonordisk.com
Company announcement no. 60/2016:
http://hugin.info/2013/R/2039453/760202.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novo Nordisk A/S via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 02.09.2016 - 23:46 Uhr
Sprache: Deutsch
News-ID 492553
Anzahl Zeichen: 1719
contact information:
Town:
Bagsvaerd
Kategorie:
Business News
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"FDA extends regulatory review period for IDegLira by three months"
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