UNION CITY, Calif., June 11 /PRNewswire-FirstCall/ —
Questcor Pharmaceuticals, Inc. (Nasdaq: QCOR) today announced that it has received
notification from the U.S. Food & Drug Administration (FDA)
that the PDUFA date for Questcor’s supplemental new drug
application (sNDA) to approve Acthar for the treatment of infantile
spasms (IS) has been extended to September
11, 2010. The FDA extended the PDUFA date in order to
review information regarding labeling and potential post-approval
commitments that they solicited from Questcor. This follows the
May 6, 2010 votes by the Advisory
Committee to the Division of Peripheral and Central Nervous System
Drugs of the FDA which indicated support for approval of this new
Acthar indication.
“We look forward to working with the FDA over the next few
months in order to finalize these critical elements,” said Don M. Bailey, President and CEO of
Questcor.
Investors should note that there can be no assurance that the
FDA will approve this sNDA by September 11,
2010, or thereafter.
About Questcor
Questcor Pharmaceuticals, Inc. is a pharmaceutical company that
markets H.P. Acthar® Gel (repository corticotropin injection).
H.P. Acthar Gel (“Acthar”) is an injectable drug that is approved
for the treatment of certain disorders with an inflammatory
component, including the treatment of exacerbations associated with
multiple sclerosis (“MS”) and to induce a diuresis or a remission
of proteinuria in the nephrotic syndrome without uremia of the
idiopathic type or that is
‘/>”/>
SOURCE