Content about Darunavir

November 12, 2012

The Food and Drug Administration has approved a new strength of a drug for HIV made by Johnson & Johnson, the drug maker said.

TITUSVILLE, N.J. — The Food and Drug Administration has approved a new strength of a drug for HIV made by Johnson & Johnson, the drug maker said.

J&J subsidiary Janssen Therapeutics announced the approval of an 800-mg formulation of Prezista (darunavir) as a once-daily treatment for HIV. The drug is designed to be taken with food at the same time as ritonavir and in combination with other HIV drugs.

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.

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 28, 2011

A subsidiary of Johnson & Johnson and Gilead Sciences will collaborate to develop a combination drug for HIV, the two companies said Tuesday.

CORK, Ireland — A subsidiary of Johnson & Johnson and Gilead Sciences will collaborate to develop a combination drug for HIV, the two companies said Tuesday.

Gilead and Tibotec Pharmaceuticals will work to create a once-daily, single-tablet combination of Tibotec’s Prezista (darunavir) and Gilead’s investigational drug cobicistat, a so-called boosting agent.

June 20, 2011

Johnson & Johnson is recalling 40,000 bottles of a drug used to treat schizophrenia due to consumer reports of the drug having a strange odor, the company said Friday.

TITUSVILLE, N.J. — Johnson & Johnson is recalling 40,000 bottles of a drug used to treat schizophrenia due to consumer reports of the drug having a strange odor, the company said Friday.

J&J subsidiary Ortho-McNeil-Janssen Pharmaceuticals announced the voluntary recall of one lot of Risperdal (risperidone) tablets in the 3-mg strength and a lot of authorized generic risperidone tablets in the 2-mg strength made by Patriot Pharmaceuticals, also a J&J subsidiary.

May 12, 2011

A subsidiary of Johnson & Johnson is recalling several batches of an HIV drug after reports of a strange odor that may have come from the shipping pallets.

HIGH WYCOMBE, United Kingdom — A subsidiary of Johnson & Johnson is recalling several batches of an HIV drug after reports of a strange odor that may have come from the shipping pallets.

Janssen-Cilag International said it would recall five lots of Prezista (darunavir) due to consumer reports of a musty or moldy smell coming from them. The odor is believed to result from traces of the chemical TBA, which is used in the construction of the pallets. The recalled lots were found in Canada, the United Kingdom, Ireland, Germany and Austria.

January 25, 2011

Johnson & Johnson posted decreases in sales for fourth quarter 2010 and for the year, according to an earnings statement released Tuesday.

NEW BRUNSWICK, N.J. — Johnson & Johnson posted decreases in sales for fourth quarter 2010 and for the year, according to an earnings statement released Tuesday.

Sales for the quarter were $15.6 billion, a 5.5% decrease from fourth quarter 2009’s $16.5 billion. Sales for the year were $61.6 billion, down by 0.5% from $61.9 billion in 2009.

Meanwhile, profits for the quarter were $1.9 billion, a 12% decrease from $2.2 billion in fourth quarter 2009. Profits for the year were $13.3 billion, an 8.7% increase over $12.3 billion in 2009.

January 3, 2011

The Food and Drug Administration has approved an update to the label of a Johnson & Johnson drug for HIV, the company said Monday.

TITUSVILLE, N.J. — The Food and Drug Administration has approved an update to the label of a Johnson & Johnson drug for HIV, the company said Monday.

Tibotec Therapeutics, a subsidiary of J&J, said the FDA approved a 200-mg formulation of Intelence (etravirine) for treating HIV in patients who have taken previous treatments and whose virus has become resistant to antiretroviral drugs.

December 14, 2010

The Food and Drug Administration has approved a revised dosage for a drug combination, which includes a Johnson & Johnson drug, in HIV patients who have received treatment but whose virus has not become immune to the J&J drug.

TITUSVILLE, N.J. — The Food and Drug Administration has approved a revised dosage for a drug combination, which includes a Johnson & Johnson drug, in HIV patients who have received treatment but whose virus has not become immune to the J&J drug.

November 18, 2010

Johnson & Johnson and the U.S. government are suing two generic drug makers to stop...

NEW YORK — Johnson & Johnson and the U.S. government are suing two generic drug makers to stop them from launching a generic drug for HIV, according to published reports.

 

Bloomberg reported Thursday that Tibotec, a subsidiary of J&J, and the government were separately suing Mylan and Lupin over a generic version of the drug Prezista (darunavir ethanolate), alleging patent infringement.

 

 

February 11, 2010

The Food and Drug Administration has approved a new formulation of an anti-retroviral drug for...

January 27, 2010

Tibotec Therapeutics announced Thursday that the Food and Drug Administration has approved a labeling update...