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

Company: Dermik Laboratories

Treatment for Facial Lipoatrophy in HIV Patients

Date of Approval: August 3, 2004

Company: Eli Lilly and Company

Treatment for Depression, Anxiety

Cymbalta is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI). Cymbalta was first approved in August 2004 for the acute treatment of major depressive disorder and has since been approved for the management of neuropathic pain associated with diabetic peripheral neuropathy and for the acute treatment of generalized anxiety disorder.
New Indication Approved: November 28, 2007
Treatment for: Maintenance Treatment of Major Depressive Disorder
Cymbalta is now also approved for the maintenance treatment of major depressive disorder (MDD) in adults.

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