New Drug Approvals: May 2004

Company: ISTA Pharmaceuticals, Inc.

Treatment for Spreading Agent

Date of Approval: May 10, 2004

Company: Braintree Laboratories, Inc.

Treatment for Bowel Preparation

HalfLytely enables patients to ingest half the volume of solution traditionally required for bowel cleansing prior to colonoscopy (a procedure used to diagnose bowel cancer and inflammatory bowel disease).

Date of Approval: May 10, 2004

Company: Vyteris, Inc.

Treatment for Local Anesthesia

LidoSite Iontophoretic Patch uses an active transdermal delivery technology known as iontophoresis, which administers medications through the skin via a mild electric current. LidoSite is used on normal intact skin to provide a local analgesia that numbs the skin prior to the administration of superficial dermatological procedures.

Date of Approval: May 10, 2004

Company: Duramed Pharmaceuticals

Treatment for Postmenopausal Symptoms

Enjuvia is the only plant-derived, synthetic conjugated estrogen product that includes the component delta 8,9-dehydroestrone sulfate, an additional active estrogenic component. Enjuvia is indicated for the treatment of menopausal vasomotor symptoms.

Company: Presutti Laboratories

Treatment for Infections

Date of Approval: May 18, 2004

Company: SkyePharma PLC and Endo Pharmaceuticals

Treatment for Pain

DepoDur is an extended-release formulation of morphine sulfate given as a single epidural injection before or during surgery to provide pain relief for up to 48 hours.

Company: Pharmion Corporation

Treatment for Myelodysplastic Syndromes (MDS)

Date of Approval: May 21, 2004

Company: Octapharma AG

Treatment for Primary Immunodeficiency Syndrome

Octagam is a liquid, ready-to-use, solvent/detergent treated immunoglobulin intravenous (IGIV) product indicated for the treatment of primary immunodeficiency diseases (PID).

Company: Salix Pharmaceuticals, Ltd

Treatment for Travelers’ Diarrhea

Date of Approval: December 31, 1969

Company: Indevus Pharmaceuticals, Inc.