GlaxoSmithKline (GSK) and FDA are notifying healthcare professionals and others of a potential association between Lexiva and myocardial infarction (heart attack) and dyslipidemia (abnormal concentrations of lipids or lipoproteins in the blood) in HIV infected adults. GSK has modified the existing Warnings and Precau
World AIDS Day was established 21 years ago by the World Health Organization to focus awareness and attention on the AIDS epidemic. It s an important reminder that HIV and AIDS are still with us, still spreading, and still claiming lives.
On December 1, 2009, the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents were revised to reflect the following changes. You can find the complete, revised guidelines on the AIDSinfo web site...
On November 24, 2009, FDA approved revisions to the INTELENCE (etravirine) labeling to include updated results through 48 weeks of dosing for the two Phase 3 trials TMC125-C206 and TMC125-C216 in treatment-experienced patients. This constitutes the required confirmatory data for Traditional approval.
On November 24, 2009, the Food and Drug Administration granted tentative approval for generic efavirenz tablets, 50 mg, 100 mg, and 200 mg under expedited review procedures for the President s Emergency Plan for AIDS Relief (PEPFAR).
On November 20, 2009, the Food and Drug Administration approved a supplemental NDA to expand the indication for Selzenttry (maraviroc) to include combination antiretroviral treatment of therapy naïve adults infected with CCR5-tropic HIV-1 virus. Maraviroc was previously approved (8/6/2007) for treatment of therapy expe
On November 23, 2009, FDA approved changes to the Norvir package insert (product label) to include drug-drug interaction information for concurrent ritonavir administration with: *inhaled medicines such as salmeterol or salmeterol in combination with fluti
On November 20, 2009, the Food and Drug Administration ( FDA ) granted tentative approval for a generic formulation of fixed dose combination lopinavir / ritonavir tablets, 200 mg/50 mg, made by Cipla Limited of Mumbai,
On November 6, 2009, the Food and Drug Administration ( FDA ) approved revised pediatric dosing recommendations that expand dosing to include children starting treatment at four weeks of age. The revised label contains the following recommendation: The recommended dosage in pediatric patients 4 weeks of age and older a
On November 5, 2009, using expedited review procedures developed to support the President s Emergency Program For AIDS Relief (PEPFAR), the Food and Drug Administration ( FDA ), granted tentative approval for lamivudine and tenofovir disoproxil fumarate fixed dose combination tablets, 300mg/300mg.
The Food and Drug Administration ( FDA ) licensed, on September 18, 2009, the Abbott Prism HIV O Plus assay, a new screening tool designed to detect the presence of antibodies to the two types of the virus that causes AIDS, HIV 1 and HIV 2. Both types can be transmitted by sexual contact, through blood, and by mother t
On September 3, 2009, FDA granted tentative approval for a generic fixed-does combination tablet containing efavirenz , lamivudine, and tenofovir disoproxil fumarate, 600mg/300mg/300mg. This new fixed-dose combination is manufactured by Matrix Laboratories Limi
New guidelines, published by the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), are available through the AIDSinfo web site to assist health care workers in preventing and treating the secondary infections that can afflict U.S. children exposed to, or infected with, HIV.
Tibotec Therapeutics, in cooperation with the U.S. Food and Drug Administration, issued a Dear Healthcare Professional letter to relay important, updated prescribing information for Intelence (etravirine) which refelects an important safety update regarding severe skin and hypersensitivity reactions.
On August 12, 2009, FDA granted tentative approval for a generic fixed dose combination product containing efavirenz /emtricitabine/fenofovir disoproxil fumarate 600 mg/200 mg/300 mg manufactured by Matrix Laboratories Limited of Hyberdad, India .
On August 6, 2009, FDA granted tentative approval for a generic formulation of lamivudine tablets, 150 mg and 300 mg, manufactured by Strides Arcolab Limited of Bangalore, India , indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. The application was revie
On August 3, 2009, the Food and Drug Administration granted tentative approval for a generic formulation of efavirenz capsules, 200 mg, manufactured by Cipla , Limited, of Mumbai, India , indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infec
On July 23, 2009, FDA granted approval for zidovudine 60 mg scored tablets for pediatric use, manufactured by Aurobindo Pharma Limited of Hyderabad, India . The application was reviewed under expedited review provisions for the President s Emergency Plan for AIDS Relief (PEPFAR). This 60 mg tablet is an alternate f
On July 23, 2009, FDA granted tentative approval to fixed dose combination lamivudine/zidovudine scored tablets, 30mg/60mg, for pediatric use, manufactured by Aurobindo Pharma Limited of Hyberdad, India . The application was reviewed under expedited review provisions for the President s Emergency Plan for AIDS Relief (
On July 16, 2009, the Food and Drug Administration ( FDA ) granted tentative approval for stavudine , lamivudine, and nevirapine fixed dose combination tablets, 40mg/150mg/200mg & 30mg/150mg/200mg manufactured by Emcure Pharmaceuticals Limited of Pune,
On July 15, 2009, FDA granted tentative approval to a fixed-dose combination tablet containing abacavir sulfate, lamivudine and zidovudine Tablets,300 mg/150 mg/300 mg, manufactured by Matrix Laboratories Limited of Hyberdad, India , indcated for use in combination with other antiretr
On July 8, 2009, FDA granted approval to Isentress (raltegravir), for the treatment of HIV-1 infection in treatment-naive patients. The recommended dose for treatment-naive adult patients is Isentress 400 mg twice daily, with or without food.
On June 22, 2009, FDA granted tentative approval for lamivudine tablets, 150 mg and 300 mg, manufactured by Matrix Laboratories Ltd of Hyberdad, India , for use in combination with other antiretrovirals in the treatment of HIV-1 infection in adults. The application was reviewed under expedited review provisions for the
FDA recently approved new labeling for Videx pediatric powder and Videx EC capsules. The revisions to the Dosage and Administration, Contraindications, Warnings and Precautions, and Drug Interactions sections in both package inserts are outlined below. Other minor changes to the package inserts were made for consist
On May 29, 2009, FDA granted tentative approval for generic lamivudine/zidovudine tablets 150 mg/300 mg indicated for treatment for Human Immunodeficiency Virus (HIV) in patients with or without Acquired Immunodeficiency Syndrome (AIDS), made by Macleods Pharmaceuticals Limited, of Daman,
The Food and Drug Administration is requiring manufacturers of two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the products labels after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with anoth
On May 7, 2009, using expedited review procedures developed to support the President s Emergency Program For AIDS Relief (PEPFAR), FDA granted tentative approval for lamivudine/zidovudine fixed dose combination tablets, 150 mg/300 mg, co-packaged with nevirapine tablets, 200 mg.
On April 26, the Acting Secretary of HHS declared a public health emergency related to the current outbreak of swine flu (now designated novel 2009 H1N1 ). In response to this public health emergency, the CDC requested Emergency Use Authorization (EUA) for the use of Tamiflu and Relenza for treatment and prophylaxis of
The Centers for Disease Control and Prevention (CDC) has published interim guidance for clinicians regarding management of patients with HIV who have been exposed to, or who have contracted the swine influenza (H1N1 virus). Any influenza carries potential risks for persons with HIV infection. Adults and adolescents wit
On April 29, 2009, FDA granted tentative approval for tenofovir disoproxil fumarate tablets, 300 mg, manufactured by Cipla , Limited, of Mumbai, India , indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infect
FDA approved, on April 20, 2009, changes to the product label for Kaletra ( lopinavir / ritonavir ) Tablets and Oral Solution, to include results from Study 730 comparing treatment with KALETRA 800/200 mg once-daily
A new AIDS awareness campaign is being launched by FDA s sister agency,the U.S. Centers for Disease Control and Prevention s (CDC). HIV is still a significant public health problem in the United Sates. Although HIV infection is preventable, every 9½ minutes, someone in the U.S. is infected with the virus. The new Act A
Labeling changes for Kaletra reflecting new QT/QTC interval and PR interval prolongation information FDA approved, on April 6, 2009, changes to the product label for Kaletra ( lopinavir / ritonavir ) Tablets and
On March 31, 2009, the Food and Drug Administration granted tentative approval for a generic formulation of nevirapine tablets, USP, 200 mg indicated for combination antiretroviral treatment of HIV-1 infection. Manufactured by MacLeods Pharmaceuticals Limited of Daman, India , this te
On March 30, 2009, FDA granted tentative approval for abacavir sulfate and lamivudine tablets, 600 mg / 300 mg, manufactured by Matrix Laboratories Limited of Hyberdad, India , for use in combination with other antiretrovirals in the treatment of HIV infection.
On March 30, FDA granted tentative approval for emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg, manufactured by Matrix Laboratories Ltd. of of Hyderabad, India ,under the expedited review provisions of the President s Emergency Plan for AIDS Relief (PEPFAR) F
On March 20, 2009, the Food and Drug Administration ( FDA ) approved a generic formulation of stavudine for oral solution, 1 mg/mL. Stavudine is a Nucleoside Reverse Transcriptase Inhibitor (NRTI) indicated for used in combination with other antiretroviral agents in the treatment of HIV infection.
The Food and Drug Administration, on March 18, 2009, granted tentative approval for stavudine and lamivudine fixed dose combination tablets, 30mg/150mg & 40mg/150mg, indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection as a component of combination therapy. Fixed dose comb
On March 16, 2009, the Food and Drug Administration granted tentative approval to a generic formulation of lamivudine tablets, 150 mg, for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. The drug is manufactured by Alkem Labs Ltd., of Mumbai, India . Tentative approval
On March 10, 2009, FDA granted tentative approval for a generic formulation of lopinavir / ritonavir Tablets, 200 mg/50 mg, manufactured by Matrix Laboratories, Ltd., of Hyderabad, India , for use in combination with other antiretroviral ag
On February 27, 2009, FDA granted tentative approval to stavudine, lamivudine and nevirapine fixed dose combination tablets,30mg/150mg/200mg & 40mg/150mg/200mg,made by Pharmacare Limited t/a Aspen Pharmacare of South Africa . The product is indicated for the treatment of HIV-1 infe
The Centers for Disease Control and Prevention (CDC) has been receiving reports of illnesses caused by a type of Salmonella called Salmonella Typhimurium, which have been traced to certain peanut products. People with impaired immune systems, such as those with HIV/AIDS, are more likely to become severely ill from a Sa
On February 18, 2009, FDA granted tentative approval for generic tenofovir disoproxil fumarate tablets, 300 mg, indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. Tentative approval means that FDA has concluded that a drug product meets all required q
On January 29, 2009, the Food and Drug Administration ( FDA ) granted traditional approval for Isentress (raltegravir) 400 mg tablets in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients. The product label and patient package insert have been updat
On January 5, 2009, FDA granted approval for generic stavudine capsules, USP, 30 mg and 40 mg, manufactured by Matrix Laboratories, Limited, Hyberdad, India . The application was originally reviewed under expedited review provisions for the President’s Emergency Plan for AIDS Relief (PEPFAR) and granted tentative appro
This information is designed to support, not replace, the relationship that exists between you and your doctor.