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FDA Approves New 800mg PREZISTA® darunavir Tablet




 



2012 NOV 26 (NewsRx) -- By a News Reporter-Staff News Editor at AIDS Weekly -- Janssen Therapeutics, Division of Janssen Products, LP, announced the U.S. Food and Drug Administration (FDA) has approved a new 800mg tablet of PREZISTA(®) (darunavir) for once daily oral administration for the treatment of human immunodeficiency virus (HIV-1) in treatment-naive and treatment-experienced adult patients with no darunavir resistance-associated mutations. PREZISTA(®) is always taken with and at the same time as ritonavir with food and in combination with other HIV medicines (see also Janssen Therapeutics).

The new tablet strength will allow patients taking PREZISTA(®) once daily to reduce the number of PREZISTA(®) tablets by half, taking one 800mg tablet instead of two 400mg tablets once a day with ritonavir 100mg and other antiretroviral medications.

The 800mg tablet is expected to be available shortly. Janssen plans to discontinue the PREZISTA(®) 400mg tablet, which will become obsolete as a result of the introduction of the 800mg tablet. To help physicians and patients transition to the new tablet, Janssen will provide educational materials about the new tablet to pharmacies. PREZISTA(®) 800mg tablets will be added to medicines covered by the Janssen Therapeutics Patient Savings Program as well as those covered by the Johnson & Johnson Patient Assistance Foundation.

"The single 800mg tablet provides an option for a reduced pill burden and reflects our ongoing commitment to offer more treatment options for the diverse population of people living with HIV," said Bryan Baugh, MD, Medical Director at Janssen Therapeutics.

Keywords for this news article include: Genetics, HIV/AIDS, RNA Viruses, Retroviridae, HIV Infections, Vertebrate Viruses, Government Agencies, Janssen Therapeutics, Offices and Entities, Primate Lentiviruses, Human Immunodeficiency Virus, Viral Sexually Transmitted Diseases.

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Information in this article was accurate in November 26, 2012. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.