Type Action /(Date)

BioTime Inc.


Blood plasma volume expander

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.


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)


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

FDA sent company a complete review letter (6/17)