Replacement of blood volume during surgery in which substantial amounts of blood are lost
FDA sent company a letter confirming it had completed its review of the NDA and requested clarifications (11/20)
Cephalon Inc. and Chiron Corp.
Myotrophin
Mecasermin; recombinant human insulin-like growth factor (injection)
Amyotrophic lateral sclerosis
FDA stated that product is potentially approvable, subject to submission of additional information from ongoing studies showing product¿s effectiveness in treating disease (5/12)
CellPro Inc.
Ceprate SC Instrument II
2nd-generation cell-separation device
Stem-cell concentration device
FDA sent company an approvable letter (7/13)
Diatide Inc. and Nycomed-Amersham (U.K.)
NeoTect (a.k.a. P289)
Synthetic, somatostatin-type receptor-binding peptide P829, designed to attach to targeted disease molecules and labeled with technetium-99m
In vivo imaging agent for non-small-cell lung cancer
Company received approvable letter (12/17)
Elan Corp. plc (Ireland)
Zonegran
Zonisamide capsules; blocks voltage-sensitive sodium and calcium channels
Adjunctive therapy in treating partial seizures in adults with epilepsy
FDA sent company an approvable letter (3/24)
Seragen Inc. (OTC Bulletin Board: SRGN) and Ligand Pharmaceuticals Inc.
Ontak (DAB389IL-2)
Denileukin diftitox; interleukin-2 (IL-2) fusion protein consisting of diphtheria toxin fragment A-fragment B genetically fused to human IL-2 (targets high-affinity IL-2 receptors on activated T cells)
Recurrent or persistent cutaneous T cell lymphoma in adult patients who have received prior therapy
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