New Drug Approvals Archive

Get news by email or subscribe to our news feeds.

August 2004

August 2

Epzicom (abacavir and lamivudine) Tablets

Date of Approval: August 2, 2004
Company: GlaxoSmithKline
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 (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 (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 (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: Diabetic Nephropathy, Fibromyalgia, Neuropathic Pain, Depression, Generalized Anxiety Disorder, Osteoarthritis, Pain

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.

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 (estradiol acetate) FDA Approval History

September 7

Cymbalta (duloxetine)

New Indication Approved: September 3, 2004

Cymbalta (duloxetine) FDA Approval History

February 26

Cymbalta (duloxetine)

New Indication Approved: February 23, 2007

Cymbalta (duloxetine) FDA Approval History

November 30

Cymbalta (duloxetine)

New Indication Approved: November 28, 2007

Cymbalta (duloxetine) FDA Approval History

June 16

Cymbalta (duloxetine)

New Indication Approved: June 13, 2008

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

Sculptra (injectable poly-L-lactic acid) FDA Approval History

November 30

Cymbalta (duloxetine)

New Indication Approved: November 30, 2009

Cymbalta (duloxetine) FDA Approval History

November 5

Cymbalta (duloxetine)

New Indication Approved: November 4, 2010

Cymbalta (duloxetine) FDA Approval History

July 16

Truvada (emtricitabine and tenofovir)

New Indication Approved: July 16, 2012

Truvada (emtricitabine and tenofovir) FDA Approval History

Hide
(web1)