Content about Tenofovir

January 31, 2014

Mylan announced that its India-based subsidiary, Mylan Pharmaceuticals Private Limited, has been named Gilead Sciences' branded medicines business partner for India.

PITTSBURGH and MUMBAI, India — Mylan announced that its India-based subsidiary, Mylan Pharmaceuticals Private Limited, has been named Gilead Sciences' branded medicines business partner for India.

Under this exclusive agreement, Mylan will market and distribute in India the following drugs from Gilead:

December 27, 2013

The Food and Drug Administration has approved an HIV pill made by Gilead Sciences for patients who are switching from other therapy regimens, the company said.

FOSTER CITY, Calif. — The Food and Drug Administration has approved an HIV pill made by Gilead Sciences for patients who are switching from other therapy regimens, the company said.

Gilead said the FDA approved its single-pill regimen, Complera (emtricitabine; rilpivirine; tenofovir disoproxil fumarate) for use in adult patients who have suppressed their infections on stable antiretroviral regimens and are replacing their current regimens. The FDA originally approved the drug in 2011.

December 4, 2013

The availability of new generic drugs for treating HIV will erode sales of HIV antiretroviral drugs into the next decade in developed countries, according to a new report.

BURLINGTON, Mass. — The availability of new generic drugs for treating HIV will erode sales of HIV antiretroviral drugs into the next decade in developed countries, according to a new report.

Healthcare market research firm Decision Resources released the report Wednesday, showing that sales of antiretroviral drugs in the United States, France, Germany, the United Kingdom, Spain, Italy and Japan would be $13.1 billion in 2022, down from 2012's $13.4 billion.

April 30, 2013

The Food and Drug Administration declined to approve two drugs for HIV made by Gilead Sciences for which the company was seeking approval for use as part of treatment regimens.

FOSTER CITY, Calif. — The Food and Drug Administration declined to approve two drugs for HIV made by Gilead Sciences for which the company was seeking approval for use as part of treatment regimens.

April 4, 2013

The Food and Drug Administration has given preliminary approval to a drug made by Aurobindo Pharma for treating HIV infection, the drug maker said.

HYDERABAD, India — The Food and Drug Administration has given preliminary approval to a drug made by Aurobindo Pharma for treating HIV infection in developing countries, the drug maker said.

Aurobindo announced that it had received tentative approval for efavirenz/emtricitabine/tenofovir disoproxil fumarate combination tablets in the 600-mg/200 mg/300-mg strength. The drug is a generic version of Gilead Sciences' Atripla.

December 28, 2012

Teva Pharmaceuticals USA will delay the sales of generic versions of two Gilead Sciences HIV drugs until June 2013, the company stated.

NEW YORK — Teva Pharmaceuticals USA will delay the sales of generic versions of two Gilead Sciences HIV drugs until June 2013, the company stated. The decision comes pending a long-running patent suit in the U.S. District Court for the Southern District of New York.

Teva may launch generics for Truvada (i.e., emtricitabine/tenofovir disoproxil fumarate) and Viread (i.e., tenofovir disoproxil fumarate) on June 1 if there is no ruling holding that the patents-in-suit are invalid or unenforceable, according to an agreement filed between the drug makers Nov. 27.

August 3, 2012

Mylan and Gilead Sciences have made an agreement under which Mylan will have rights to produce and market generic versions of Gilead drugs for HIV and AIDS in developing countries.

PITTSBURGH — Mylan and Gilead Sciences have made an agreement under which Mylan will have rights to produce and market generic versions of Gilead drugs for HIV and AIDS in developing countries.

The agreement, involving Gilead and Mylan subsidiary Mylan Labs Ltd., centers around drugs containing emtricitabine, the active ingredient in such drugs as Emtriva, and such fixed-dose combinations as Truvada (emtricitabine and tenofovir disoproxil fumarate) and the experimental Quad.

July 16, 2012

The Food and Drug Administration has approved a drug used to treat HIV for reducing the risk of HIV infection, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug used to treat HIV for reducing the risk of HIV infection, the agency said Monday.

June 29, 2012

Drug maker Gilead Sciences has submitted a regulatory approval application to the Food and Drug Administration for a drug designed to increase the blood levels of certain drugs for HIV.

FOSTER CITY, Calif. — Drug maker Gilead Sciences has submitted a regulatory approval application to the Food and Drug Administration for a drug designed to increase the blood levels of certain drugs for HIV.

May 14, 2012

A Food and Drug Administration expert panel has recommended approval of a drug made by Gilead Sciences for treating HIV, the drug maker said Friday.

FOSTER CITY, Calif. — Gilead Sciences scored a second favorable Food and Drug Administration expert panel vote as the FDA's Antiviral Drugs Advisory Committee recommended on Friday that the regulatory agency approve an experimental drug designed to treat HIV.

May 11, 2012

An expert panel at the Food and Drug Administration has recommended that the agency approve a drug made by Gilead Sciences for lowering the risk of infection by the virus that causes AIDS.

FOSTER CITY, Calif. — An expert panel at the Food and Drug Administration has recommended that the agency approve a drug made by Gilead Sciences for lowering the risk of infection by the virus that causes AIDS.

May 9, 2012

The Food and Drug Administration may be close to approving a drug for preventing HIV infection, according to published reports.

NEW YORK — The Food and Drug Administration may be close to approving a drug for preventing HIV infection, according to published reports.

The Associated Press reported that the FDA had said Truvada (emtricitabine and tenofovir disoproxil fumarate), made by Gilead Sciences, appeared to be safe and effective for preventing HIV infection when taken daily. An FDA advisory committee will review the drug and decide whether to recommend its approval for pre-exposure prophylaxis, or PrEP.

February 14, 2012

The Food and Drug Administration is giving priority review to a drug made by Gilead Sciences that the company is investigating for the prevention of HIV.

FOSTER CITY, Calif. — The Food and Drug Administration is giving priority review to a drug made by Gilead Sciences that the company is investigating for the prevention of HIV.

Gilead said the FDA gave the special designation to its application for Truvada (emtricitabine and tenofovir disoproxil fumarate) for pre-exposure prophylaxis, or PrEP, to reduce the risk of HIV infection. The FDA originally approved Truvada for treating HIV infection in 2004, and it is currently the most prescribed antiretroviral drug in the United States.

January 19, 2012

The Food and Drug Administration has approved a lower-dose formulation of a drug made by Gilead Sciences for treating HIV in children, the company said.

FOSTER CITY, Calif. — The Food and Drug Administration has approved a lower-dose formulation of a drug made by Gilead Sciences for treating HIV in children, the company said.

Gilead announced the FDA approval of Viread (tenofovir disoproxil fumarate) in the 150-mg, 200-mg and 250-mg strengths combined with other antiretroviral drugs in patients ages 6 to 12 years while also approving an oral powder formulation for children ages 2 to 5 years. The agency approved the drug in the 300-mg strength for adults in 2001 and for patients ages 12 to 17 years in 2010.

January 3, 2012

The Food and Drug Administration has accepted a regulatory approval application from Gilead Sciences for a drug to treat HIV, the company said.

FOSTER CITY, Calif. — The Food and Drug Administration has accepted a regulatory approval application from Gilead Sciences for a drug to treat HIV, the company said.

Gilead said the FDA planned to review the application for the Quad by Aug. 27.

The Quad combines four Gilead drugs — Truvada (emtricitabine and tenofovir disoproxil fumarate), cobicistat and elvitegravir — into one pill. The last drug was licensed from Japan Tobacco.

December 20, 2011

The World Health Organization has approved three generic second-line treatments for HIV made by Mylan, the drug maker said Tuesday. The drugs will be delivered to people in developing countries living with HIV and AIDS.

PITTSBURGH — The World Health Organization has approved three generic second-line treatments for HIV made by Mylan, the drug maker said Tuesday. The drugs will be delivered to people in developing countries living with HIV and AIDS.

August 11, 2011

The Food and Drug Administration has approved a new single-pill treatment for HIV made by Gilead Sciences and Johnson & Johnson, Gilead said.

FOSTER CITY, Calif. — The Food and Drug Administration has approved a new single-pill treatment for HIV made by Gilead Sciences and Johnson & Johnson, Gilead said.

Gilead announced the approval of Complera (emtricitabine, rilpivirine, tenofovir disoproxil fumarate). The drug combines Gilead's Truvada with J&J's Edurant.

July 19, 2011

Ranbaxy will produce and market three HIV/AIDS drugs that currently are in late-stage clinical development by Gilead under a new licensing agreement between the drug makers.

GURGAON, India — Ranbaxy will produce and market three HIV/AIDS drugs that currently are in late-stage clinical development by Gilead under a new licensing agreement between the drug makers.

July 13, 2011

Taking drugs for treating HIV might reduce the risk of infection among heterosexual couples, according to two new studies conducted in Africa.

NEW YORK — Taking drugs for treating HIV might reduce the risk of infection among heterosexual couples, according to two new studies conducted in Africa.

One study, funded by the Bill & Melinda Gates Foundation and conducted among 4,758 couples in Kenya and Uganda, found that when taken daily, Gilead’s Viread (tenofovir) reduced the rates of infection by at least 62% compared with placebo. Truvada (tenofovir and emtricitabine), another drug made by Gilead, reduced infection risk by 73%.

February 14, 2011

Gilead Sciences has refiled an approval application with the Food and Drug Administration for an HIV drug, the drug maker said.

FOSTER CITY, Calif. — Gilead Sciences has refiled an approval application with the Food and Drug Administration for an HIV drug, the drug maker said.

Gilead said it had resubmitted its application for a single-tablet combination of Truvada (emtricitabine and tenofovir disoproxil fumarate) and Johnson & Johnson subsidiary Tibotec Pharmaceuticals’ investigational drug TMC278 (rilpivirine hydrochloride) to treat HIV-1 infection in adults.

November 22, 2010

NEW YORK A daily dose of an anti-retroviral pill appears to prevent HIV infection, according to results of a study conducted by University of California at San Francisco researchers, published in The New England Journal of Medicine on Tuesday.

September 12, 2010

An investigational treatment for HIV by Gilead Sciences that combines four drugs in one tablet...

FOSTER CITY, Calif. An investigational treatment for HIV by Gilead Sciences that combines four drugs in one tablet works as well as a drug already on the market, Gilead said Monday.

 

July 18, 2010

A combination therapy comprising of drugs made by Abbott and Merck is as effective as...

June 1, 2010

Three new drugs for treating HIV from Gilead Sciences and J&J subsidiary Tibotec could have...

January 31, 2010

Teva is hoping to release its version of an HIV drug before the drug’s patents...