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New Drug Approvals Archive - August 2004

August 2004

Epzicom (abacavir and lamivudine) Tablets

Date of Approval: August 2, 2004
Company: ViiV Healthcare
Treatment for: HIV Infection

Epzicom (abacavir and lamivudine) is a combination of two nucleoside reverse transcriptase inhibitors (NRTIs) indicated for use with other antiretroviral drugs for the treatment of HIV-1 infection in adults.

Truvada (emtricitabine and tenofovir) Tablets

Date of Approval: August 2, 2004
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection, Pre-Exposure Prophylaxis

Truvada (emtricitabine and tenofovir disoproxil fumarate) is a combination of nucleoside analog HIV-1 reverse transcriptase inhibitors indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection, and for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in people at high risk.

Sculptra (injectable poly-L-lactic acid)

Date of Approval: August 3, 2004
Company: Sanofi-aventis U.S.
Treatment for: Facial Lipoatrophy; Facial Wrinkles

Sculptra (injectable poly-L-lactic acid) 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. Sculptra Aesthetic is indicated for the correction of shallow to deep nasolabial fold (smile lines) contour deficiencies and other facial wrinkles in healthy patients.

Cymbalta (duloxetine) Delayed-Release Capsules

Date of Approval: August 3, 2004
Company: Eli Lilly and Company
Treatment for: Neuropathic Pain, Pain, Osteoarthritis, Generalized Anxiety Disorder, Depression, Fibromyalgia, Diabetic Nephropathy

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

Femtrace (estradiol acetate) Tablets

Date of Approval: August 20, 2004
Company: Warner Chilcott
Treatment for: Postmenopausal Symptoms

Marketing Status: Discontinued

Femtrace (estradiol) is an oral estrogen indicated for the relief of postmenopausal vasomotor symptoms.

New Drug Approvals Archive

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