New Drug Approvals: August 2004

Date of Approval: August 2, 2004

Company: GlaxoSmithKline

Treatment for HIV Infection

Epzicom contains two widely-used nucleoside reverse transcriptase inhibitors (NRTIs) in one tablet, dosed once a day. Epzicom combines 300 mg of Epivir (lamivudine, 3TC) and 600 mg of Ziagen (abacavir sulfate, ABC) and is used with other antiretroviral drugs for the treatment of HIV-1 infection in adults.

Company: Gilead Sciences, Inc.

Treatment for HIV Infection

Date of Approval: August 3, 2004

Company: Dermik Laboratories

Treatment for Facial Lipoatrophy

Sculptra is a dermal filler indicated for the restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.

Date of Approval: August 3, 2004

Company: Eli Lilly and Company

Treatment for Depression, Anxiety, Fibromyalgia, Diabetic Neuropathy

Cymbalta is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI). Cymbalta is indicated for the treatment of major depressive disorder, neuropathic pain associated with diabetic peripheral neuropathy, generalized anxiety disorder and fibromyalgia.

Company: Hameln Pharmaceuticals GmbH

Treatment for Internal Contamination from Radioactive Elements

Date of Approval: August 20, 2004

Company: Warner Chilcott

Treatment for Menopausal Vasomotor Symptoms

Femtrace is an oral estrogen medicine indicated for the relief of moderate-to-severe hot flashes or night sweats of menopause.

Company: Schering Corp.

Treatment for Nasal Symptoms of Allergies

Company: Schwarz Pharma, Inc.

Treatment for Parkinson’s Disease