Drug/indication: Ampligen for chronic fatigue syndrome
FDA decision date: May 25 Hemispherx announced May 26 that the FDA requested a "brief delay" of one to two weeks to take action on the Ampligen application. But on a July 22 conference call, the company said it may get a response from the FDA in the fall. NeurogesX (NGSX)
Drug/indication: Qutenza for neuropathic pain
FDA decision date: Aug. 16 Qutenza is a skin patch that delivers a form of capsaicin through the skin to alleviate nerve pain. The patch/drug recently received approval in Europe. Cell Therapeutics (CTIC)
Drug/indication: pixantrone for non-Hodgkin's lymphoma
FDA acceptance date: Aug. 24
Tentative FDA approval decision date: Dec. 24 The FDA will inform Cell Therapeutics on Aug. 24 whether it has accepted pixantrone for review under a priority, six-month review clock. If pixantrone is granted priority review, the FDA approval decision date would be Dec. 24.