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New Drug Approvals Archive - August 2004

August 2004

August 2	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. Epzicom GlaxoSmithKline - Treatment for HIV Infection Epzicom (abacavir and lamivudine) FDA Approval History
August 2	Truvada (emtricitabine and tenofovir) Tablets Date of Approval: August 2, 2004 Company: Gilead Sciences, Inc. Treatment for: HIV Infection 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 in adults. Truvada Gilead Sciences, Inc. - Treatment for HIV Infection Truvada (emtricitabine and tenofovir) FDA Approval History
August 3	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. Sculptra Dermik Laboratories - Treatment for Facial Lipoatrophy in HIV Patients Sculptra (injectable poly-L-lactic acid) FDA Approval History
August 3	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. FDA Approves Cymbalta for the Treatment of Depression Cymbalta (duloxetine) FDA Approval History
August 20	Femtrace (estradiol acetate) Tablets Date of Approval: August 20, 2004 Company: Warner Chilcott Treatment for: Postmenopausal Symptoms Femtrace (estradiol) is an oral estrogen indicated for the relief of postmenopausal vasomotor symptoms. Femtrace Warner Chilcott - Treatment for Menopausal Vasomotor Symptoms Femtrace (estradiol acetate) FDA Approval History
September 7	Cymbalta (duloxetine) New Indication Approved: September 3, 2004 FDA Approves Cymbalta for Neuropathic Pain Associated With Diabetes Cymbalta (duloxetine) FDA Approval History
February 26	Cymbalta (duloxetine) New Indication Approved: February 23, 2007 FDA Approves Cymbalta for Treatment of Generalized Anxiety Disorder Cymbalta (duloxetine) FDA Approval History
November 30	Cymbalta (duloxetine) New Indication Approved: November 28, 2007 FDA Approves Cymbalta for Maintenance Treatment of Major Depressive Disorder Cymbalta (duloxetine) FDA Approval History
June 16	Cymbalta (duloxetine) New Indication Approved: June 13, 2008 FDA Approves Cymbalta for the Management of Fibromyalgia Cymbalta (duloxetine) FDA Approval History
July 29	Sculptra (injectable poly-L-lactic acid) New Formulation Approved: July 29, 2009 Treatment for: Facial Lipoatrophy; Facial Wrinkles FDA Approves Sculptra Aesthetic, a Facial Injectable for Correction of Nasolabial Folds and Other Facial Wrinkles Sculptra (injectable poly-L-lactic acid) FDA Approval History
November 30	Cymbalta (duloxetine) New Indication Approved: November 30, 2009 FDA Approves Cymbalta for Maintenance Treatment of Generalized Anxiety Disorder Cymbalta (duloxetine) FDA Approval History
November 5	Cymbalta (duloxetine) New Indication Approved: November 4, 2010 FDA Clears Cymbalta to Treat Chronic Musculoskeletal Pain Cymbalta (duloxetine) FDA Approval History
July 16	Truvada (emtricitabine and tenofovir) New Indication Approved: July 16, 2012 FDA Approves Truvada for Reducing the Risk of Sexually Acquired HIV Infection Truvada (emtricitabine and tenofovir) FDA Approval History

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