Company

Products

Description

Indication

Action

Cephalon Inc. and Chiron Corp.

Myotrophin

Recombinant human insulin like growth factor (IGF-1)

Amyotrophic lateral sclerosis

FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted not to recommend approval, citing equivocal clinical results (5/8); FDA extended review after companies submitted amendment (8/11); companies withdrew and resubmitted NDA extending review by six months (11/11)

DepoTech Corp. and Chiron Corp.

DepoCyt

Injectable, sustained-release formulation of chemotherapeutic agent cytarabine (uses DepoFoam, lipid-based drug delivery)

Neoplastic meningitis arising from solid tumors

FDA's Oncologic Drug Advisory Committee recommended against approval (12/18)

Genzyme Corp.

Sepracoat

Coating solution for tissue surfaces in thoracic or peritoneal cavity; made from chemically modified hyaluronic acid

To reduce post-operative adhesions (as result of indirect surgical trauma) in abdominal and pelvic surgery

FDA's General and Plastic Surgery Devices Panel voted not to recommend approval (company failed to establish efficacy) (5/5)

Ilex Oncology Inc. and Sanofi SA (France)

Zyrkamine (MGBG)

Mitoguazone dihydride for injection; inhibits polyamines

2nd-line treatement for AIDS-related non-Hodgkin's lymphoma

FDA's Oncologic Drug Advisory Panel recommended against approval (6/23)

Sequus Pharmaceuticals Inc.

Amphotec

Lipid-based colloidal dispersion of amphotericin B

Empiric treatment of neutropenia in patients with fever of unknown origin

FDA's Antiviral Drugs Advisory Committee voted not to recommend approval (patient sample size not large enough to prove efficacy) (4/14)


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