Questcor Pharmaceuticals, Inc. (Headquarters) Receives Notification of PDUFA Date Extension to September 11, 2010
Published: Jun 14, 2010
"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.
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 due to lupus erythamatosus. In addition, Acthar is not indicated for, but is used in treating patients with infantile spasms ("IS"), a rare form of refractory childhood epilepsy, and opsoclonus myoclonus syndrome, a rare autoimmune-related childhood neurological disorder. The Company also markets Doral® (quazepam), which is indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. For more information, please visit www.questcor.com.