On December 22, 2006, the Food and Drug Administration approved Radiesse, an injectable (under the skin) implant to restore or correct signs of facial lipidatrophy, or fat loss, in people with human immunodeficiency virus (HIV). Radiesse, a sterile, semi-solid cohesive implant consisting of synthetic calcium hydroxylap
The Food and Drug Administration, on December 19, 2006, granted tentative approval for efavirenz Capsules, 50 mg, 100 mg, and 200 mg., manufactured by Aurobindo Pharma Limited Inc., of Hyderabad, India . This is a generic version of the already-approved Su
The following these instructions is important for everyone, but especially for those most vulnerable to foodborne illness- including those with weakened immune systems due to conditions such as HIV/AIDS. The U. S. Food and Drug Administration ( FDA ) reminds consumers to pay special attention to the handling of eggs an
In an effort to enable more patients who lack satisfactory alternatives to have access to unapproved medicines, while balancing the need to safeguard the individual patient and ensure the continued integrity of the scientific process that brings safe and effective drugs to the market, on December 11, 2006,
Today, December 1, is World AIDS Day. This year s international theme is Stop AIDS: Keep the Promise. Started in 1988, World AIDS Day represents many things to many people. For some, it s about increasing awareness of HIV/AIDS, or an opportunity to remember those lost to AIDS, while others see World AIDS Day as an oppo
The Food and Drug Administration ( FDA ) is warning healthcare professionals regarding the significantly increased risk for serious and life-threatening cardiovascular (CV) complications associated with normalization of hemoglobin levels in patients receiving erythropoiesis-stimulating agents (ESAs). Epoetin alfa i
On November 17, 2006, the Food and Drug Administration ( FDA ) granted tentative approval for a new fixed drug combination of stavudine/lamivudine/ nevirapine tablets manufactured by Cipla Limited, of Mumbai, India
The Food and Drug Administration, on November 6, 2006, granted tentative approval for a generic formulation of abacavir sulfate tablets, 300 mg, manufactured by Cipla Limited of Mumbai, India . The application was reviewed under the expedited
Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection have been revised. The revision represents a major rewriting of the main document to improve its organization and readability. Because the main document has been almost completely rewritten, there is no highlighting of changes to either its text
The Food and Drug Administration ( FDA ) announced, on October 18, 2006, the availability of a guidance for industry entitled Fixed Dose Combinations (FDC), Co-Packaged Drug Products and Single Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV. The guidance encourages sponsors to develop v
On October 16, 2006, the Food and Drug Administration approved a new 300 mg capsule form of Reyataz ( atazanavir ). Reyataz is now available as 100mg, 150 mg, 200 mg, and the new 300 mg capsules. The new 300 mg capsules give treatment-experienced patients the option to take either one 300 mg capsule, or two 150 mg caps
On October 10, 2006, the DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents released a new revision of the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. The following are among changes that have been made to the May 4, 2006 version of the guidelines: * The Pan
The Food and Drug Administration, on October 5, 2006, granted tentative approval for didanosine for Oral Solution (Pediatric Powder), 10 mg/mL, manufactured by Aurobindo Pharma Limited Inc., of Hyderabad, India . This is a generic version of the already-approved
The U.S. Food and Drug Administration ( FDA ) has approved the APTIMA HIV-1 RNA Qualitative Assay, manufactured by Gen-Probe Incorporated (San Diego, Calif.). The APTIMA assay, which detects the RNA--the nucleic acid or genetic material--of the HIV-1 virus, is the first test approved for the detection of HIV-1 RNA to h
The Food and Drug Administration ( FDA ), on September 13, 2006, granted tentative approval for a fixed dose tablet containing lamivudine/zidovudine 150 mg/300 mg manufactured by Cipla Limited of Mumbai, India . The tablets are indicated for use in combination with other antiret
The Food and Drug Administration ( FDA ) will hold a public meeting of its Antiviral Drugs Advisory Committee on October 19 and 20, 2006,to discuss design issues in the development of products for treatment of chronic Hepatitis C, including co-infection with HIV. The meeting will be held on October 19, 2006, from 8 a.m
On August 28, 2006, FDA granted tentative approval for stavudine capsules, 30 mg and 40 mg, manufactured by Strides Acrolab Ltd., Bangalore, India , under the expedited review provisions created for the President s Emergency Plan for AIDS Relief
The Food and Drug Administration is advising consumers to avoid eating raw oysters harvested in the Pacific Northwest as a result of increased reports of illnesses associated with the naturally occurring bacteria Vibrio parahaemolyticus (Vp) in oysters harvested from the area. Oysters harvested from this region have be
bioMerieux, Inc. has become aware of five HIV-1 finished kit lots in the field which have been reported to contain EnzAbody reagent that appears noticeably cloudy and/or flocculent, instead of clear and non-turbid as expected 30 minutes after reconstitution. Kit lot numbers identified are 121566, 121567, 121568, 160342
The Food and Drug Administration granted tentative approval on July 26, 2006 for lamivudine/zidovudine tablets co-packaged with abacavir sulfate tablets for treatment of HIV, manufactured by Aurobindo Pharma Limited Inc., of Hyderabad, India . The lamivudine/zidovudine combination is a generic formulation of the approv
The Food and Drug Administration ( FDA ) today (July 12, 2006) approved Atripla Tablets, a new fixed-dose combination of three widely used antiretroviral drugs, to be taken in a single tablet once a day, alone or in combination with other antiretroviral products for the treatment of HIV-1 infection in adults. Atripla i
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 has been revised to include an update of the Antiretroviral Drug Resistance and Resistance Testing in Pr
The Food and Drug Administration, on July 10, 2006, granted tentative approval for didanosine tablets (chewable, dispersible, buffered), 100 mg, 150 mg and 200 mg, manufactured by Aurobindo Pharma Limited Inc., of Hyderabad, India . This is a generic version of the already-approved
The Food and Drug Administration ( FDA ) today (June 30, 2006) issued the first tentative approval for a fixed-dose, three-ingredient tablet for use as a complete anti-viral treatment of human immunodeficiency virus (HIV-1) infection in adults. The product, (lamivudine-zidovudine-
Today (June 30, 2006), Boehringer Ingelheim and FDA informed Healthcare Professionals about important new findings related to Aptivus (tipranavir) capsules, co-administered with ritonavir , 500mg/200mg. Boehringer Ingelheim identified 14 reports of intracranial hemor
The Food and Drug Administration, on June 27, 2006, granted tentative approval for Abacavir Sulfate Oral Solution, 20 mg/mL, manufactured by Aurobindo Pharma Limited Inc., of Hyderabad, India . This is a generic version of the already-approved
The Food and Drug Administration, on June 27, 2006, granted tentative approval for stavudine 15 and 20 mg capsules manufactured by Aurobindo Pharma Limited Inc., of Hyderabad, India . Tentative approval was granted to the same manufacturer for generic stavudine, 30 and 40 mg capsules on July 1, 2005, and for Oral Solut
The Food and Drug Administration today, June 23, 2006, granted accelerated approval for Prezista (darunavir - formerly known as TMC-114), a new drug for treatment experienced adults whose infection with the human immunodeficiency virus (HIV) is not responding to treatment with other antiretroviral drugs. Prezista, a pr
The Food and Drug Administration ( FDA ) granted tentative approval on June 22, 2006 for generic lamivudine - oral solution, 10 mg/mL manufactured by Cipla Limited, Mumbai, India . This action represents the second tentative approval of a generic version of the already FDA appro
FDA published, this week, a final Guidance for Industry on Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency to assist sponsors in the development of antiviral drugs and biological products (i.e., therapeutic proteins and monoclonal antibodies) from the initial pre-IND through th
Apparently some people have had problems with the link to the CCR5 meeting webcast page. The purpose of the meeting is to discuss issues regarding the development of CCR5 co-receptor antagonists for the treatment of HIV infection Please use http://www.hivforum.org/CCR5/webcast.html if you experienced a problem accessin
FDA /Forum for Collaborative HIV Research Collaborative Meeting on Long-Term Safety Concerns Associated with CCR5 Antagonist Development Wednesday, May 31, 2006 The Forum for Collaborative HIV Research and the FDA s Division of Antiviral Products will host an open public meeting on May 31, 2006 to discuss issues rega
The Food and Drug Administration ( FDA ) granted, on May 18, 2006, tentative approval for a generic version of abacavir sulfate tablets, 300 mg, manufactured by Aurobindo Pharma LTD. of Hyderabad, India . Abacavir sulfate tablets are the first gen
FDA is issuing guidance providing recommendations to sponsors regarding data to support the: 1) Initiation of pediatric studies of a preventive HIV vaccine under a United States (U.S.) investigational new drug application (IND); and 2) licensure of a preventive HIV vaccine for pediatric use. The guidance also provide
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 treatment information, including new recommendations for resistance testing, treatment interruption, and HBV/HIV co-infection. Tables have been revised t
This message corrects the previous (3/29/2006) notice of a tentative approval for the capsule dosage form of zidovudine to treat HIV/AIDS. While the generic formulation does qualify for consideration under the President s Emergency Fund for AIDS Relief (PEPFAR), because patents on the original formulations have expired
On March 8, 2006, FDA granted traditional approval to two tenofovir DF containing products manufactured by Gilead Sciences , VIREAD (tenofovir disoproxil fumarate) and TRUVADA (fixed dose combination of tenofovir DF and emtricitabine). Both products are indicated for the treatmen
The Food and Drug Administration ( FDA ) on March 6, 2006, granted tentative approval for a copackaged antiretroviral drug regimen, consisting of lamivudine/zidovudine fixed dose combination tablets and efavirenz tablets, for the treatment of HIV-1 infection in adults. It is manufactured by Aurobindo Pharma Ltd.
Below is contextual information regarding the design of proposed studies to support marketing approval of Over-the-Counter (OTC) home-use HIV test kits which includes an historical overview of rapid HIV test kit approval in the United States , and key issues for consideration by the FDA Bl
FDA s Center for Biologics Evaluation and Research (CBER) will discuss the design of proposed studies to support the approval of over-the-counter (OTC) home-use human immunodeficiency virus (HIV) test kits as part of a two-day meeting of FDA s Blood Products Advisory Committee. The discussion of proposed studies to sup
The Food and Drug Administration will be conducting a public workshop entitled Behavior-Based Blood Donor Deferrals in the Era of Nucleic Acid Testing [NAT). The workshop will provide an opportunity for public discussion on the scientific basis for behavior-based donor deferral criteria, and the value of their continue
FDA and The Forum for Collaborative HIV Research have announced May 31, 2006 as the date of the open public meeting to discuss issues regarding the development of CCR5 co-receptor antagonists for the treatment of HIV infection. As described in a November 21, 2005 list serve announcement, the purpose of this meeting w
Updates to the REYATAZ (atazanavir sulfate) package insert were approved on January 25, 2006, to reflect new in vitro inhibition data and clinical drug-drug interaction information regarding coadministration of atazanavir and/or atazanavir/ ritonavir with proton pump inhibitors, H2 receptor antagonists, methadone, rifa
The U.S. Food and Drug Administration ( FDA ) today (January 18, 2006) unveiled a major revision to the format of prescription drug information, including drugs to treat HIV/AIDS, commonly called the package insert or drug label, to make information for healthcare professionals clear and concise to help ensure safe and
This information is designed to support, not replace, the relationship that exists between you and your doctor.