Emtricitabine, also known as Emtriva or FTC, is a type of medicine called a nucleoside reverse transcriptase inhibitor (NRTI). NRTIs block reverse transcriptase, a protein that HIV needs to make more copies of itself. Emtricitabine in capsule form was approved by the FDA on July 2, 2003, for use with other antiretroviral agents in the treatment of HIV infection in adults. Emtricitabine oral solution was approved by the FDA on September 28, 2005, and is now approved for use with other anti-HIV drugs in the treatment of HIV-1 infection in patients older than 3 months of age. This medicine does not cure or prevent HIV infection or AIDS and does not reduce the risk of passing the virus to other people.
Gilead Sciences, Inc. has announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg). Atripla is currently sold in the United States through a joint venture between Bristol-Myers Squibb and Gilead.
Mylan Inc. has announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.2% controlling interest, has received the first tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg.
Gilead Sciences, Inc. has announced that it has begun enrolling patients in a Phase III clinical trial of its investigational antiretroviral agent elvitegravir (GS 9137), a novel oral integrase inhibitor that is being evaluated for the treatment of HIV-1 infection.
In battle with an epidemic that has outpaced nearly all efforts to contain it, researchers are turning to strategies centered on the same antiretroviral (ARV) drugs that have been used successfully to treat HIV in hopes they will be as effective a stronghold for preventing the virus.
Prescription drugs now used to treat human immunodeficiency virus infection in adults may prevent the vaginal transmission of HIV, researchers at UT Southwestern Medical Center have found.
New research from the University of Alabama at Birmingham (UAB) shows that adding a single dose of two common anti-HIV drugs can prevent HIV-positive pregnant women from developing resistance to an entire class of drugs, potentially improving future treatment options.
Clinical trials of pre-exposure prophylaxis - that is giving anti-retroviral drugs to non-HIV-infected individuals to prevent them becoming infected - are exploring whether the approach could lead to a large decrease in transmission of the virus with few or no side effects.
Treating hepatitis B patients with the drug entecavir can cause those who are also infected with HIV to become resistant to two of the most important drugs in the anti-HIV arsenal, according to a new report in the New England Journal of Medicine.
Cross-resistance alarms raised earlier this year by Johns Hopkins researchers about a widely used antiviral therapy for hepatitis B liver infections have prompted swift treatment revisions by the drug's maker and governmental agencies.
Bristol-Myers Squibb Company and Gilead Sciences have announced the U.S. Food and Drug Administration (FDA) has granted approval of Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) for the treatment of HIV-1 infection in adults.
FDA approves Atripla Tablets, a fixed-dose combination of three widely-used antiretroviral drugs.
The Food and Drug Administration has announced the approvals of Epzicom (abacavir/lamivudine) and Truvada (tenofovir disoproxil/emtricitabine), two fixed-dose combination treatments for HIV-1 infection.
The Food and Drug Administration has announced approved Epzicom (abacavir/lamivudine) and Truvada (tenofovir disoproxil/emtricitabine), two fixed-dose combination treatments for HIV-1 infection.
Bristol-Myers Squibb Company, Gilead Sciences, Inc. and Merck & Co., Inc. have announced that they are in discussions on the development of a once-daily, fixed-dose combination of three anti-HIV drugs and are also considering certain co-packaging options for the individual products.
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