Feb 16 2010
CombinatoRx, Incorporated (NASDAQ: CRXX) today announced that the U.S.
Food and Drug Administration (FDA) has extended the Prescription Drug
User Fee Act (PDUFA) goal date for review of the Exalgo™ (hydromorphone
HCl) extended-release tablets New Drug Application (NDA) from Monday,
February 22, 2010 to Monday, March 1, 2010 due to federal government
closings.
The U.S. rights to Exalgo tablets were acquired from Neuromed by
Mallinckrodt Inc., a Covidien company, in June, 2009. Neuromed acquired
the U.S. marketing rights to Exalgo tablets from ALZA Corporation in
April 2007 and was responsible for clinical development and regulatory
filings. Covidien is responsible for all commercialization activities
for Exalgo in the U.S., including marketing, sales and all post-approval
FDA regulatory filings, and will now own the intellectual property for
the product. ALZA is responsible for manufacturing, packaging and supply
of the product. CombinatoRx and Neuromed merged on December 21, 2009.
SOURCE CombinatoRx, Incorporated