QRxPharma gets target date for MoxDuo IR FDA approval
Tuesday, 08 November, 2011
QRxPharma (ASX:QRX) announced today it has received written acceptance from the U.S. Food and Drug Administration (FDA) for review of the MoxDuo IR New Drug Application (NDA) filed earlier this year.
The FDA also set June 25, 2012 as the PDUFA (Prescription Drug User Fee Act) target date for action on the approval of the MoxDuo IR NDA.
Read more about QRxPharma and MoxDuo.
According to QRxPharma Managing Director and CEO, Dr John Holaday, this indicates the FDA is satisfied with the quality of the submission and is able to conduct a substantive review.
“We are extremely pleased with this important milestone from the FDA and – subject to approval – making plans to launch MoxDuo IR in the second half of 2012 for the treatment to moderate to severe acute pain,” said Holaday.
The FDA notification included useful technical information on chemistry, manufacturing and controls (CMC), as well as the paediatric program to be conducted after drug approval that would enable further marketing exclusivity.
The NDA is the basis for U.S. regulatory approval of MoxDuo IR for the treatment of moderate to severe acute pain, a $2.5 billion segment of the $8 billion spent annually on prescription opioids in the U.S., according to QRxPharma.
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