Content about Antiretroviral drugs

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.

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.

June 14, 2012

Kadmon Pharmaceuticals earlier this month announced that it has launched a new 600 mg/day dose pack of Ribasphere RibaPak (ribavirin, USP), Kadmon's proprietary ribavirin regimen available in a daily, two-pill compliance package for enhanced therapy adherence.

NEW YORK — Kadmon Pharmaceuticals earlier this month announced that it has launched a new 600 mg/day dose pack of Ribasphere RibaPak (ribavirin, USP), Kadmon's proprietary ribavirin regimen available in a daily, two-pill compliance package for enhanced therapy adherence.

The new dose pack is designed to provide added dosing control to improve the management of hemolytic anemia in certain patients prescribed the triple therapy of a protease inhibitor, pegylated alpha interferon and ribavirin for the treatment of chronic hepatitis C virus infection.

May 23, 2012

A generic antiretroviral drug for treating HIV infection has won approval from the Food and Drug Administration.

PITTSBURGH — A generic antiretroviral drug for treating HIV infection has won approval from the Food and Drug Administration.

Mylan announced Wednesday the approval of nevirapine tablets in the 200-mg strength. The drug is a generic version of Boehringer Ingelheim's Viramune. Mylan plans to begin shipping the drug immediately.

Various versions of the drug had sales of $116.6 million during the 12-month period ended in March, according to IMS Health.

 

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.

February 23, 2012

The Food and Drug Administration has given tentative approval to a division of Mylan for a generic drug for treating HIV and AIDS in children in developing countries.

PITTSBURGH — The Food and Drug Administration has given tentative approval to a division of Mylan for a generic drug for treating HIV and AIDS in children in developing countries.

Mylan said Thursday that the FDA had tentatively approved Mylan Labs' abacavir sulfate and lamivudine tablets in the 60 mg/30 mg strength. The drug is a generic version of Viiv Healthcare's Epzicom and was approved under the President's Emergency Plan for AIDS Relief. The drug will only be available for purchase in certain developing countries outside the United States.

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 6, 2012

The Food and Drug Administration has granted fast-track designation to a drug currently under development by Achillion Pharmaceuticals for hepatitis C, the company said.

NEW HAVEN, Conn. — The Food and Drug Administration has granted fast-track designation to a drug currently under development by Achillion Pharmaceuticals for hepatitis C, the company said.

December 21, 2011

The Food and Drug Administration has approved an HIV drug for children and adolescents, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved an HIV drug for children and adolescents, the agency said Wednesday.

The FDA announced the approval of Merck's Isentress (raltegravir) for HIV-1 infection in patients ages 2 to 18 years. The chewable form of the drug will be available for children ages 2 to 11 years.

"Many young children and adolescents are living with HIV, and this approval provides an important additional option for their treatment," FDA Office of Antimicrobial Products director Edward Cox said.

 

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.

December 2, 2011

Under the President's Emergency Plan for AIDS Relief, the Food and Drug Administration has given tentative approval to a generic HIV and AIDS drug made by Mylan, the company said.

PITTSBURGH — Under the President's Emergency Plan for AIDS Relief, the Food and Drug Administration has given tentative approval to a generic HIV and AIDS drug made by Mylan, the company said.

The drug maker's Mylan Labs subsidiary received tentative approval for atazanavir sulfate and ritonavir tablets in the 300-mg/100-mg strength. The FDA's tentative approval of the drug under PEPFAR means it will be eligible for purchase in certain developing countries.

October 6, 2011

Gilead Sciences has signed an agreement with Boehringer Ingelheim to gain exclusive worldwide rights to research, develop and commercialize BI's novel anti-retroviral compounds.

FOSTER CITY, Calif., and INGELHEIM, Germany — Gilead Sciences has signed an agreement with Boehringer Ingelheim to gain exclusive worldwide rights to research, develop and commercialize BI's novel anti-retroviral compounds.

Under the terms of the agreement, Gilead will pay the German drug maker an upfront payment and possibly will receive additional payments based upon the achievement of certain development, regulatory and commercial milestones, as well as royalties on future net sales, the companies said.

September 20, 2011

Mylan subsidiary Matrix Labs has received tentative approval from the Food and Drug Administration for its new drug application of a co-packaged antiretroviral treatment under the President's Emergency Plan for AIDS Relief.

PITTSBURGH — Mylan subsidiary Matrix Labs has received tentative approval from the Food and Drug Administration for its new drug application of a co-packaged antiretroviral treatment under the President's Emergency Plan for AIDS Relief.

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 18, 2011

A statin made by Eli Lilly and Kowa Pharmaceuticals America appears to work well with drugs used to treat HIV, according to a study presented at the sixth International AIDS Society conference on HIV Pathogenesis, Treatment and Prevention in Rome.

INDIANAPOLIS — A statin made by Eli Lilly and Kowa Pharmaceuticals America appears to work well with drugs used to treat HIV, according to a study presented at the sixth International AIDS Society conference on HIV Pathogenesis, Treatment and Prevention in Rome.

The study was designed to investigate potential interactions between Livalo (pitavastatin) and Abbott’s antiretroviral protease inhibitor Kaletra (lopinavir and ritonavir). The study found that each drug had only a minimal effect on the other.

June 20, 2011

A generic drug maker has been granted approval from the Food and Drug Administration to manufacture its version of a urinary tract infection treatment.

SUPPLIER NEWS — A generic drug maker has been granted approval from the Food and Drug Administration to manufacture its version of a urinary tract infection treatment. Amneal Pharmaceuticals said that its nitrofurantoin oral suspension in the 25-mg/5-mL strength is the first-to-market generic version of Furadantin, made by Shionogi Pharma. Amneal will sell its generic in 8-oz. (230-mL) size bottles, the company said. Annual U.S. sales of nitrofurantoin oral suspension totaled $40 million for the year ended in January, according to IMS Health data.


May 20, 2011

The Food and Drug Administration has approved a new antiretroviral treatment for HIV made by Johnson & Johnson, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new antiretroviral treatment for HIV made by Johnson & Johnson, the agency said Friday.

The FDA approved J&J subsidiary Tibotec Therapeutics’ Edurant (rilpivirine) as a treatment for use in combination with other HIV drugs in adults who have not been treated before.

April 25, 2011

SUPPLIER NEWS — Hi-Tech Pharmacal announced the tentative approval by the Food and Drug Administration of levofloxacin oral solution in the 25-mg/mL strength, a generic antibiotic. Levofloxacin oral solution is a generic version of Johnson & Johnson’s Levaquin, which had sales of $6 million in 2010, according to IMS Health. Hi-Tech expected to receive final approval in June, when Johnson & Johnson’s patent expires.


April 5, 2011

The Food and Drug Administration has approved Boehringer Ingelheim Pharmaceuticals' single-pill antiretroviral for HIV-1 patients, BI said Tuesday.

RIDGEFIELD, Conn. — The Food and Drug Administration has approved Boehringer Ingelheim Pharmaceuticals' single-pill antiretroviral for HIV-1 patients, BI said Tuesday.

The FDA approved Viramune XR (nevirapine), a single-pill, once-daily, extended-release formulation of nevirapine for use in combination with other antiretroviral drugs.

March 10, 2011

A subsidiary of Mylan has won approval to sell a generic drug for HIV and AIDS in developing countries under the President’s Emergency Plan for AIDS Relief.

PITTSBURGH — A subsidiary of Mylan has won approval to sell a generic drug for HIV and AIDS in developing countries under the President’s Emergency Plan for AIDS Relief.

Mylan announced Thursday that Matrix Labs won Food and Drug Administration approval for zidovudine tablets in the 100-mg strength. The drug is a generic version of ViiV Healthcare’s Retrovir, an antiretroviral sold as a water-dispersible tablet. The drug is designed to treat HIV and AIDS in children and prevent transmission of the virus from pregnant mothers to their children.

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.

December 7, 2010

The Food and Drug Administration has given tentative approval to a generic drug for HIV/AIDS made by Mylan subsidiary Matrix Labs for distribution in developing countries under the President’s Emergency Plan for AIDS Relief, Mylan said Tuesday.

PITTSBURGH — The Food and Drug Administration has given tentative approval to a generic drug for HIV/AIDS made by Mylan subsidiary Matrix Labs for distribution in developing countries under the President’s Emergency Plan for AIDS Relief, Mylan said Tuesday.

The tentative approval under PEPFAR covers Matrix’s abacavir sulfate tablets in the 60-mg strength. The drug is a generic version of ViiV Healthcare’s Ziagen, and is used to treat the disease in children.

October 4, 2010

The Food and Drug Administration has approved a generic drug for HIV made by a...

PITTSBURGH The Food and Drug Administration has approved a generic drug for HIV made by a subsidiary of Mylan under a program that supplies drugs to people living with HIV in developing countries, Mylan said Tuesday.