Content about Fixed-dose combination

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.

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.

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.

October 27, 2011

Drug makers Bristol-Myers Squibb and Gilead Sciences announced an agreement to develop and commercialize a fixed-dose combination treatment for patients with HIV.

FOSTER CITY, Calif. — Drug makers Bristol-Myers Squibb and Gilead Sciences announced an agreement to develop and commercialize a fixed-dose combination treatment for patients with HIV.

The two companies said the drug will combine Bristol's Reyataz (atazanavir sulfate) and Gilead's boosting agent cobicistat, which is designed to increase blood levels of certain HIV medicines to potentially allow for one-pill, once-daily dosing. Gilead is currently studying Reyataz and cobicistat in phase-2 and phase-3 trials.

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 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.

January 20, 2011

The Food and Drug Administration has given tentative approval to an antiretroviral treatment for children with HIV and AIDS under the President’s Emergency Plan for AIDS Relief program.

PITTSBURGH — The Food and Drug Administration has given tentative approval to an antiretroviral treatment for children with HIV and AIDS under the President’s Emergency Plan for AIDS Relief program.

Mylan announced Thursday that its subsidiary, Matrix Labs, had received the tentative approval for lamivudine and zidovudine tablets in the 30-mg/60-mg strength. The drug is a generic version of Combivir, made by ViiV Healthcare, a company specializing in HIV and AIDS created as a partnership between Pfizer and GlaxoSmithKline.

January 31, 2010

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