FDA Submissions, Approvals And Other Actions: January 2002

Company
(Symbol)

Product

Description

Indication

Status (Date)

CANCER

Atrix Labora-
tories Inc.
(ATRX)

Eligard (formerly Leuprogel One-month Depot)

One-month treatment; leuprolide acetate that is injected subcutaneously using Atrix's Atrigel drug delivery system

Advanced prostate cancer

FDA approved Eligard 7.5 mg (1/24)

Corixa Corp.
(CRXA)

Bexxar

Radioimmunotherapy antibody conjugated to iodine-131

Non-Hodgkin's lymphoma

FDA's Oncologic Drugs Advisory Committee is delaying a hearing on the drug because it needs more time to go through the material (1/10)

IDEC Pharma-
ceuticals
Corp. (IDPH)

Zevalin

Radiolabeled mouse monoclonal antibody targeted against the CD20 antigen; ibritumomab tiuxetan

Non-Hodgkin's lymphoma

Company's launch of the product is delayed due to manufacturing concerns of the FDA (1/8)

CARDIOVASCULAR

Hemosol Inc.
(Canada; HMSL;
TSE:HML)

Hemolink

Oxygen therapeutic

Cardiac bypass grafting surgery

FDA gave Hemosol notice to proceed with a clinical trial of Hemolink in "re-do" cardiac by-pass grafting surgery (1/31)

InterMune
Inc. (ITMN)

Actimmune

Interferon gamma 1b injection

Idiopathic pulmonary fibrosis

FDA granted fast-track designation for Actimmune (1/7); a Data Safety Monitoring Board recommended the company continue the 330-patient Phase III trial (1/17)

CENTRAL NERVOUS SYSTEM

Chiron Corp.
(CHIR)

Betaseron

Interferon beta-1b

Multiple sclerosis

FDA approved a new room-temperature formulation of Betaseron for subcutaneous injection (1/15)

INFECTION

Aviron Inc.
(AVIR)

FluMist

Intranasal influenza
vaccine

Influenza

Company submitted to the FDA a formal reply to the complete response letter the FDA sent Aviron on Aug. 31, related to its BLA for FluMist (1/8)

INFLAMMATION AND PAIN

Immunex
Corp. (IMNX)

Enbrel

Tumor necrosis factor-inhibiting drug; etanercept

Psoriatic arthritis

FDA approved Enbrel for this additional indication (1/16)

MISCELLANEOUS

ISTA Pharma-
ceuticals Inc. (ISTA)

Vitrase

Injectable enzyme; hyaluronidase

Severe vitreous hemorrhage

Company submitted the initial section of the NDA to the FDA (1/4)

Sepracor
Inc. (SEPR)

Xopenex

Levalbuterol HCl
inhalation solution

Treatment or prevention of bronchospasm in children with reversible obstructive airway disease

FDA pproved Xopenex in children ages 6 to 11; it was previously approved for patients ages 12 and older (1/31)

Transkaryotic Therapies Inc. (TKTX)

Iduronate-2-
sulfatase

Enzyme replacement therapy

Hunter syndrome

The product was given orphan drug status in both Europe and the U.S. (1/3)

Notes:

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

TSE = Toronto Stock Exchange

BLA = Biologics License Application; NDA = New Drug Application