Company*
(Symbol)

Product

Description

Indication

Status (Date)


CANCER

Cell Pathways
Inc.
(CLPA)

Aptosyn

Exisulind

Lung cancer

An Independent Data and Safety Monitoring Board recommended resuming enrollment in the company's Phase III trial (11/12)

Cell Thera-
peutics Inc.
(CTIC)

Trisenox
(FDA-
approved)

Arsenic trioxide injection

Chronic myeloid and acute myelocytic leukemias

Company received orphan drug designation for Trisenox (11/29)

ImClone
Systems
Inc.
(IMCL) and
Bristol-Myers
Squibb Co.

Erbitux
(formerly
IMC-
C225)

Monoclonal antibody targeting and blocking epidermal growth factor receptor

Irinotecan-refractory colorectal cancer

Companies completed the rolling BLA (11/1)

Matrix Pharm-
aceutical Inc.
(MATX)

IntraDose

Cisplatin/epinephrine injectable gel

Recurrent or refractory head and neck cancer

Company received a non-approvable letter from the FDA (11/6)

NeoPharm
Inc.
(NEOL)

IL13-
PE38

Tumor-targeting product

Malignant glioma

FDA granted orphan drug status to IL13-PE38 (11/26)

SuperGen Inc.
(SUPG)

¿

Daunorubicin

Acute leukemias

FDA granted approval (11/21)

Zarix Inc.*

Thymitaq

Nolatrexed
dihydrochloride

Hepatocellular carcinoma

FDA granted orphan drug designation to Thymitaq (11/5)

CARDIOVASCULAR

Actelion Ltd.
Switzerland;
(SWX:ATLN)
and Genentech
Inc.
(NYSE:
DNA)

Tracleer

Bosentan; active endothelin receptor antagonist

Pulmonary
arterial hypertension

FDA approved Tracleer (11/21)

CENTRAL NERVOUS SYSTEM

Amgen Inc.
(AMGN)

Kineret

Anakinra; an interleukin-1 receptor antagonist

Rheumatoid arthritis

FDA gave Amgen clearance to market Kineret (11/14)

Celgene
Corp.
(CELG)
and Novartis
Pharmaceu-
ticals Corp.

Focalin

Dexmethylphenidate HCl; a refined version of Ritalin

Attention deficit/ hyperactivity disorder

FDA granted marketing approval (11/15)

Vernalis
Group plc
(UK; LSE:
VER)

Frova-
triptan

5HT 1B/1D agonist

Migraine

FDA approved frovatriptan (11/9)

MISCELLANEOUS

Nexell
Therapeu-
tics Inc.
(NEXL)

¿

Therapeutic stem cell product

Chronic granulomatous disease

FDA granted orphan drug status (11/28)

Northfield
Laborator-
ies
Inc.
(NFLD)

Poly-
Heme

A solution of polymerized hemoglobin that has a longer shelf life than blood

Blood substitute

FDA said it needs additional information before it can accept the BLA (11/20)

Orphan
Medical Inc.
(ORPH)

Xyrem

Sodium oxybate; oral solution

Cataplexy in narcolepsy

FDA cleared the company's contract manufacturer to produce certain classes of drugs, including Xyrem, addressing one of the issues cited in the FDA's approvable letter issued in July; the other issues were addressed in a response letter to the FDA dated in October (11/8)


Notes:

* Privately held

Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.

LSE = London Stock Exchange; NYSE = New York Stock Exchange; SWX = Swiss Stock Exchange

BLA = Biologics License Application

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