The Food and Drug Administration ( FDA ) has approved a marketing application (PMA) for the Multispot HIV-1/HIV-2 Rapid Test. This device is indicated for the detection and differentiation of circulating antibodies associated with HIV-1 and HIV-2 in human plasma and serum, as an aid in the diagnosis of infection with
The Clinical Pharmacology section of the Crixivan ( indinavir ) label has been revised to include pharmacokinetic data from a study (PACTG 358) in HIV-infected pregnant women. Results from this study show substantially reduced indinavir concentrations in women at
Bristol-Meyers Squibb has issued a Dear Healthcare Provider letter regarding important new pharmacokinetic data concerning the coadministration of REYATAZ (atazanavir) and Norvir ( ritonavir ) with Prilosec (omeprazole). Omeprazole is a proton- pump inhibitor (PPI)
FDA approved, on December 17, 2004, a new 500 mg tablet formulation of the HIV protease inhibitor, INVIRASE ( saquinavir mesylate). The dosage and administration for INVIRASE in adults (over the age of 16 years) is 1000 mg twice a day (taken as either two 500 mg tablets or five 200 mg capsules) in combin
The Food and Drug Administration ( FDA ) today (December 3, 2004) approved a generic formulation of Didanosine (ddI) Delayed Release capsules, 200 mg, 250 mg, and 400 mg for use in combination with other antiretroviral agents in the treatment of HIV-1 infection in adults.
The Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection have been updated. The Pediatric Guidelines, developed by the Working Group on Antiretroviral Therapy and Medical Management of HIV-Infected Children, now include Supplement II, titled Managing Complications of HIV Infection in HIV-Infected
Today is World AIDS Day. From the first, isolated reports in 1981, AIDS has grown into a global pandemic. It affects every corner of the world. Despite efforts in every nation, the epidemic continues to grow. Today the face of AIDS is increasingly young and female. Globally, women account for nearly half the adults liv
The Food and Drug Administration ( FDA ) has issued final guidance on the Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV. FDA
Bristol-Myers Squibb (BMS) is issuing a Dear Healthcare Provider letter regarding its important new clinical data regarding coadministration of Viread ( tenofovir disoproxil fumarate [TDF]),
What s New in the Document? - This guidelines revision represents a major rewriting of the document to improve its organization and readability. The tables are updated with the most current available information. The following major changes have been made to the March 28, 2004 version of the guidelines: Changes in Reco
The Kaletra ( lopinavir and ritonavir ), Soft Gel Capsules and Oral Solution, labeling has been revised to include long-term (week 144-204) efficacy and safety results from two phase II trials.
FDA approved, on October 15, 2004, a supplemental new drug application for Fuzeon (enfuvirtide, also known as T-20) injection, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in treatment experienced patients with ongoing viremia, granting traditional approval. FDA originall
Department of Health and Human Services Public Health Service Food and Drug Administration 5100 Paint Branch Parkway College Park, MD 20740 SEP 20 2004 WARNING LETTER CERTIFIED MAIL RETURN RECEIPT REQUESTED Cellular Wellness Foundation P.O. Box 1181 Santa Maria, CA 93456-1181 Dear Sir or Madam: The Food and Drug Admini
Sustiva labeling has been revised to include safety and efficacy data representing 168 weeks of treatment from Study 006 ( efavirenz + lamivudine + zidovudine vs indinavir + lamivudine + zidovudine vs efavirenz + indinavir) and other available data.
Department of Health and Human Services Public Health Service Food and Drug Administration 5100 Paint Branch Parkway College Park, MD 20740 AUG 13 2004 WARNING LETTER VIA CERTIFIED MAIL RETURN RECEIPT REQUESTED VIRALSOL 5550 Camino Besar Yorba Linda, CA 92887 Dear Sir or Madam: This is to advise you that the Food and D
The Food and Drug Administration today, August 3, 2004, approved Sculptra, an injectable filler to correct facial fat loss in people with human immunodeficiency virus (HIV). Sculptra is the first such treatment approved for a condition known as lipoatrophy, or facial wasting, a sinking of the cheek, eye and temple area
FDA announced approval today, August 2, 2004, of two fixed-dose combination (FDC) antiretroviral drug products for use with other antiretroviral agents for the treatment of HIV-1 infection. The FDCs are GlaxoSmithKline s EPZICOM(tm) ( abacavir /lamivudine) and Gi
The Food and Drug Administration has developed a web page to consolidate records of advisory committee meetings related to HIV/AIDS and associated conditions, making them easier to access. The new page, which lists HIV/AIDS-related advisory committee meetings held since 1996, indexed by topic and by year, can be found
On July 6, 2004, the Division of Antiviral Drug Products approved a new dosing regimen for REYATAZ. In antiretroviral-experienced patients the new recommended dose is: REYATAZ 300 mg (two 150 mg capsules) once daily plus ritonavir 100 mg once daily taken taken with food. For antiretroviral-naïve patients the recomm
On July 1, 2004, the VIREAD ( tenofovir disoproxil fumerate) label was updated to include the following information. The Box Warning was updated to include the following: VIREAD IS NOT INDICATED FOR THE TREATMENT OF CHRONIC HEPATITIS B VIRUS (HBV) INFECTION AND THE SAFETY AND EFFICACY OF VIREAD HAVE NOT BEEN ESTABLISHE
FDA granted a CLIA (Clinical Laboratory Improvements Amendments of 1988] waiver to the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test for use with oral fluid on June 25, 2004. The OraQuick ADVANCE Rapid HIV Test is a fast and non-invasive test approved on March 26, 2004, to detect antibodies to HIV-1 in oral fluid. The
FDA and Bristol-Myers Squibb recently notified healthcare professionals of revisions to the CLINICAL PHARMACOLOGY and PRECAUTIONS sections of the product labeling for DESYREL (trazodone hydrochloride) Tablets, indicated for the treatment of depression. In vitro drug metabolism studies suggest that there is a pote
Richard Klein, HIV/AIDS Program Director - Office of Special Health Issues
FDA published on May 20, 2004 a new Final Rule on donor eligibility for human tissues and cells (Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products), and draft guidance (Guidance for Industry Eligibility Determination for Donors of Human Cells, Tissues, and Cellular a
Richard Klein, HIV/AIDS Program Director - Office of Special Health Issues
FDA announced, on May 17, 2004, issuance of a guidance document that describes a process to expedite approval of low cost, safe and effective co-packaged and fixed dose combination (FDC) HIV therapies so that high quality drugs can be made available in Africa and developing countries around the world under the Presid
Boehringer Ingelheim Pharmaceuticals recently issued a Dear Health Care Professional letter regarding clarification of risk factors for severe, life-threatening and fatal hepatotoxicity with VIRAMUNE ( nevirapine ). A copy of the letter and revised labeling can be found at www.
FDA approved, on December 23, 2003, the Uni-Gold Recombigen(TM) HIV rapid HIV test, a single use rapid test for the detection of antibodies to HIV-1 in plasma, serum and whole blood (venipuncture). It is the first device to be FDA approved for use with all three sample types. Uni-Gold Recombigen HIV is intended for u
This information is designed to support, not replace, the relationship that exists between you and your doctor.