The Food and Drug Administration ( FDA ), on December 27, 2005, granted tentative approval, through an expedited procedure, to generic Nevirapine Oral Suspension, 50 mg/5 mL, manufactured by Aurobindo Pharma LTD., of Hyderabad,
The Food and Drug Administration ( FDA ) granted, on December 21, 2005, tentative approval to generic stavudine for Oral Solution, 1 mg/mL manufactured by Aurobindo Pharma LTD., of Hyderabad, India . This product is the first generic version of the approved product,
The Food and Drug Administration ( FDA ) today announced the tentative approval of Stavudine (stav yoo deen) for Oral Solution, 1 mg/mL to be manufactured by Aurobindo Pharma LTD. of Hyderabad, India .
On December 16th, 2005, The Centers for Disease Control and Prevention (CDC) issued an MMWR Dispatch regarding recent reports of a higher than expected number of false positive test results in certain geographic areas using the oral fluid rapid test for HIV. The Dispatch is available at http://www.cdc.gov/mmwr/preview/
This week marks the tenth anniversary of the approval of the first protease inhibitor. In December of 1995, a then new class of drug for the treatment of HIV/AIDS in combination with other antiretroviral drugs represented an historic landmark in the treatment of HIV/AIDS. Protease inhibitors helped establish a new trea
-- Use of Products Could lead to Severe Infections The Food and Drug Administration ( FDA ) is advising consumers not to use Miracle II Neutralizer and Miracle II Neutralizer Gel products manufactured by Tedco, Inc., in West Monroe, Louisiana because the products are bacterially contaminated and have not been proven to
After reviewing the current CCR5 antagonist development issue, the FDA CCR5 Antagonist Review Group and the Forum for Collaborative HIV Research have decided to postpone the meeting to discuss the long-term follow up of patients enrolled in CCR5 antagonist clinical trials until February or March of 2006. The origin
December 1 is World AIDS Day. From the first, isolated reports in 1981, AIDS has grown into a global pandemic. Despite efforts in every nation, the epidemic continues to grow. While HIV/AIDS seems to have faded somewhat into the background in the United States , rarely making front page headlines as it has in years pas
The Forum for Collaborative HIV Research and the FDA s Division of Antiviral Products are preparing to convene a joint open public meeting on January 18, 2006. The purpose of the meeting is to discuss issues regarding the development of CCR5 co-receptor antagonists for the treatment of HIV infection, specifically mecha
The Food and Drug Administration ( FDA ) recently published information about proposed changes in the way condoms are to be regulated, and draft guidelines for condom labeling. FDA sets regulatory controls on medical devices. The least restrictive level is general controls. General controls can include good manufacturi
The Public Health Service Task Force Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV-1 Transmission in the United States have been revised to include: Updates to Clinical Scenario #3. The new information discusses a 3 to 7 da
The Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection has been updated. The new version includes: 1. Information about the recently approved protease inhibitor tipranavir and information about new formulations of emtricitabine and lopinavir /
The Food and Drug Administration ( FDA ) today announced the tentative approval of Lamivudine Oral Solution, 10 mg/mL manufactured by Aurobindo Pharma LTD. of Hyderabad , India . Lamivudine Oral Solution is the first generic version of the
Today (October 28, 2005) the Food and Drug Administration approved a new formulation of Kaletra . Kaletra ( lopinavir / ritonavir ) is now available as a film coated tablet (200mg/50mg) that provides advantages over the c
The Food and Drug Administration ( FDA ) is announcing a meeting of its Blood Products Advisory Committee (BPAC) to discuss important issues that include an approach for home-use rapid HIV test kits. The Committee will hear a proposal by OraSure Technologies, Inc. for over-the-counter (OTC) availability of the OraQuick
On October 6, 2006, The Food and Drug Administration approved dosing recommendations for NORVIR (ritonavir) in pediatric patients one month to two years of age. The major revisions to the package insert include the following: CLINICAL PHARMACOLOGY This section was modified to include pharmacokinetic data in children 1
On September 28, 2005, The Food and Drug Administration approved EMTRIVA (emtricitabine) Oral Solution 10 mg/mL. The approval of this Oral Solution formulation allows for dosing recommendations in pediatric patients. EMTRIVA is now indicated in combination with other antiretroviral agents, for the treatment of HIV-1 in
Some HIV-infected patients may have interrupted their antiretroviral therapy and other medications due to the recent hurricane disasters. The following link provides some guidance to the general practitioners attending to the medical needs of displaced HIV-infected adult or pediatric patients who have not yet secured H
On September 19, 2005, FDA approved several generic formulations of Zidovudine for the U.S. market. Previously, the products had been only tentatively approved and were not available in the United States because patent or market exclusivity blocked their approval for domestic marketing. With the expiration of those pat
The Food and Drug Administration ( FDA ) today, September 7, 2005, announced the tentative approval of zidovudine oral solution manufactured by Aurobindo Pharma LTD. Hyderabad, India . This product is the first tentatively approved generic version of Retrovir brand of the zidovudine oral solution (manufactured by
The Food and Drug Administration, on August 25, 2005, granted tentative approval to zidovudine 300 mg tablets manufactured by Aurobindo Pharma LTD., Hyderabad, India . Tentative approval means that although existing patents and/or exclusivity prevent marketing of this product in the United
FDA , in collaboration with The University of Medicine and Dentistry of New Jersey, The National Institute of Mental Health, The National Institute on Drug Abuse, and The Centers for Disease Control and Prevention is announcing a consensus conference, PDE-5 Inhibition and HIV Risk: Current Concepts and Controversies.
The Food and Drug Administration within the U.S. Department of Health and Human Services (HHS/ FDA ) today announced the tentative approval of zidovudine tablets manufactured by Ranbaxy Laboratories Limited of Guragon, India . This product contains 300 mg of zidovudine in each
The Food and Drug Administration ( FDA ), on July 7, 2005, granted tentative approval for a generic combination drug product consisting of lamivudine and zidovudine, manufactured by Aurobindo Pharma LTD. Hyderabad, India . FDA tentative approval means that the product meets all of FDA s quality, safety and eff
The Food and Drug Administration ( FDA ) today announced the tentative approval of stavudine capsules manufactured by Aurobindo Pharma LTD., Hyderabad, India . This formulation of stavudine is the first generic version of the approved drug, Ze
The Food and Drug Administration ( FDA ) today (June 24, 2005) granted tentative approval for efavirenz tablets manufactured by Aurobindo Pharma LTD. of Hyderabad, India . This product is the first tentatively approved generic version of Susti
On June 22, 2005, the US Food and Drug Administration ( FDA ) granted accelerated approval of APTIVUS (tipranavir), a protease inhibitor. APTIVUS, co-administered with 200 mg of ritonavir , is indicated for use as part of combination antiretroviral treatment of HIV-1 infected adult patients with evidence of vi
The Food and Drug Administration ( FDA ) announced, on June 20, 2005, the Tentative Approval of two applications for nevirapine tablets manufactured by Ranbaxy Laboratories Limited, Guragon, India and Aurobindo Pharma Limited, Hyderabad, India.
Today, June 15, 2005, FDA granted a tentative approval for generic lamivudine tablets, 150 mg and 300 mg, manufactured by Aurobindo Pharma Ltd., Hyderabad, India . Lamivudine tablets are indicated for use in combination with other antir
FDA issued an approval on May 31, 2005 for a generic formulation of foscarnet sodium injection, 24 mg/mL, 250 mL and 500 mL single-dose containers, manufactured by Pharmaforce, Inc., of Columbus, Ohio. The product is indicated for the treatment of CMV retinitis in patients with acquired immunodefic
FDA granted a tentative approval for a generic formulation of lamivudine tablets, 150 mg, manufactured by Ranbaxy Laboratories Limited ( India ), for use in combination with other antiretroviral agents in the treatment of HIV-1 infection in adults.
Roche Pharmaceuticals, of Nutley, New Jersey, has issued a Dear Health Care Provider letter to inform the clinical community that commercial distribution of Fortovase , the 200-mg soft-gel formulation of saquinavir , will be discontinued by February 15, 2006.
The Food and Drug Administration ( FDA ) is issuing draft guidance to assist product sponsors in the development of antiviral drug products and to serve as a starting point for understanding the nonclinical and clinical virology data important to support clinical trials of antiviral agents. This guidance focuses on non
On May 12, 2005, the FDA approved a new 30-count bottle for Norvir ( ritonavir ) Soft Gelatin Capsules, 100 mg. Previously only 120-count bottles were available. The new 30-count bottle is more convenient for pharmacy dispensing, and
On May 12, 2005, FDA approved new labeling for Viread ( tenofovir disoproxil fumarate). The label was updated to include results from Study 903, specifically, the 144 week efficacy and safety data in treatment-naïve patient
FDA today approved the use of KALETRA 800/200mg once-daily administration for the treatment of HIV-infection in therapy-naive adult patients, based on review and analysis of two clinical trials comparing safety and efficacy of lopinavir (LPV)/ rit
Adult Treatment Guidelines Updated The Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents has been revised to include up-to-date drug information, including updated information on nevirapine hepatotoxicity risks, the interaction between rifampin and ritonavir-boosted
Bristol-Myers Squibb Company has issued a Dear Health Care Provider Letter highlighting important information about Sustiva and pregnancy. The contents of the letter are reproduced below. March 2005 Re: Important Change in SUSTIVA (efavirenz) Package Insert - Change from Pregnancy Category C
On March 29, 2005, FDA approved Baraclude (entecavir) for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication, and either evidence of persistent elevations in serum aminotransferases (ALT or AST), or histologically active disease.
The Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection have been updated, March 24, 2005. Please note that the Appendix, Characteristics of Available Antiretroviral Drugs, has been extensively modified to include up-to-date drug information, including updated information about pediatric dosing a
Roche Laboratories Inc. has issued a Dear Health Care Provider letter to communicate an important drug interaction warning for saquinavir / ritonavir , used as part of combination the
The Food and Drug Administration ( FDA ) is warning consumers not to use unapproved home-use diagnostic test kits that have been marketed nationwide via the Internet by Globus Media, Montreal, Canada . In fact, no home-use test kits intended for diagnosing HIV*, syphilis and dengue fever are approved for sale in the U
The Food and Drug Administration ( FDA ) today is announcing the tentative approval of a copackaged antiretroviral drug regimen, consisting of lamivudine/zidovudine fixed dose combination tablets and nevirapine tablets for the treatment of HIV-1 infection in adults.
The Food and Drug Administration ( FDA ) is issuing a public health advisory to inform health care providers and patients about recent safety-related changes to the nevirapine ( Viramune ) label (package insert) and about appropriate u
This information is designed to support, not replace, the relationship that exists between you and your doctor.