The Reyataz ( atazanavir ) package insert has been updated to include important drug-drug interaction information regarding the administration of Reyataz with or without ritonavir and nevirapine ,
The Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection have been revised. The new version includes updated information on: Recommended antiretroviral regimens for initial therapy Nelfinavir, which now meets FDA limits for ethyl methane sulfonate (EMS) The changes in this revision are highlighted
On July 18, 2008, FDA approved changes to the package insert for Ziagen (abacavir sulfate) highlighting information about the association of the HLA-B*5701 allele (a part of a gene) and hypersensitivity reactions (HSR) caused by abacavir-containing therapy.
On June 26, 2008, FDA granted approval for a generic Zidovudine Oral Solution USP, 50 mg/5 mL formulation manufactured by Cipla Limited of of Mumbai, India . The is a full approval, meaning that this generic zidovudine formulation can be marketed in the United States .
On June 24, 2008, FDA approved labeling changes to the Viramune ( nevirapine ) oral solution and tablets to reflect various updates, including: -Dosing recommendations for pediatric patients 15 days to 2 months of age.
The Kaletra ( lopinavir / ritonavir ) Tablet and Oral Solution labels were updated to include dosing recommendations for pediatric patients 14 days to 6 months of age and from 12 to 18 years of age.
On June 23, 2008, FDA approved a new Aptivus (tipranavir) oral solution (100 mg/mL). The product label has been updated to include dosing recommendations for pediatric patients 2-18 years of age. In addition, information regarding oral and parenterally administered midazolam was updated in the Contraindication and Drug
On June 19, 2008, FDA granted tentative approval to fixed dose combination lamivudine/ stavudine tablets, 30mg/6mg & 60mg/12mg for oral suspension for pediatric use, manufactured by Cipla Limited of Mumbai, India .
The CDC is publishing important information in the Mortality and Morbidity Weekly Report (MMWR) about false-positive oral fluid rapid tests for HIV, reported in New York City between 2005 and 2008. The information highlights the importance of confirmatory testing, as required by product labeling, to confirm both oral f
Roche Laboratories , Inc. has updated their package insert for their protease inhibitor, Invirase (saquinavir) to include the following drug interaction information and include new warnings regarding coadministration of Invirase/ ritonavir and digoxin (used in the tr
On May 9, 2008, FDA granted tentative approval for a generic formulation of emtricitabine capsules, 200 mg, manufactured by Aurobindo Pharma Limited, Hyberdad, India , for use in combination with other antiretrovirals in the treatment of HIV infection. The application was reviewed under expedited review provisions for
On May 15, 2008, FDA granted tentative approval for a generic formulation of nevirapine tablets, 200 mg, manufactured by Matrix Laboratories Limited, Hyberdad, India , for use in combination with other antiretrovirals in the treatment of HIV infection.
On March 27, 2008, FDA approved a new HIV diagnostic test, the VITROS Anti-HIV 1+2 Reagent Pack and VITROS Anti-HIV 1+2 Calibrator, manufactured by Ortho-Clinical Diagnostics. The VITROS Anti-HIV 1+2 Reagent Pack and VITROS Anti-HIV 1+2 Calibrator is an in vitro chemiluminescent immunoassay intended for the in vitro qu
FDA has been made aware of recent, preliminary findings from analyses of data collected from The Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Study, a large observational study of 33,347 HIV-1 infected patients living in North America, Europe and Australia . Patients in this study are
The Reyataz ( atazanavir ) Capsule label has been updated to include the dosing recommendations for pediatric patients 6 to 18 years of age. REYATAZ should not be administered to pediatric patients below the age of 3 months due to the risk of kernicterus (a type of brain damage caused by excessive levels of bilirubin)
On March 20, 2008, the Food and Drug Administration ( FDA ) granted tentative approval to two fixed-dose combination products containing generic versions of stavudine /lamivudine/ nevirapine 30mg/150mg/200mg Tablets, and stavudine/lamivudine/nevirapine
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 PREZISTA (darunavir) tablets, that includes a warning about Hepatotoxicity. The letter provides, in addition to other information, the fol
Updates have been made to Prezista (darunavir) tablets labeling to reflect significant new risk information. Changes have been made to the CLINICAL PHARMACOLOGY section to include data from 6 pharmacokinetic, drug interaction Phase 1 trials, and to the WARNINGS, PRECAUTIONS AND ADVERSE REACTIONS sections of the package
On February 29, 2008, FDA granted tentative approval for two generic formulations of drugs used to treat HIV/AIDS. Stavudine capsules, 15 mg, 20 mg, 30 mg, and 40 mg., and efavirenz tablets, 600 mg, all manufactured by Hetero Drugs Limited, Hyberd
The Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection have been revised. The new version includes updated information on: When to initiate therapy, including Change in treatment recommendations for when to initiate therapy in HIV-infected children Reduction from 4 to 3 age bands for recommendat
On February 25, 2008, FDA approved a new 600 mg tablet strength for Prezista (darunavir), manufactured by Tibotec, Inc., Yardley, PA. The new 600 mg tablet facilitates dosing by reducing pill burden. The recommended oral dose of Prezista tablets is 600 mg (two 300 mg tablets or one 600 mg tablet) twice daily taken with
On February 14, 2008, FDA granted approval for a generic formulation of Zidovudine Tablets, 300 mg., manufactured by Matrix Laboratories, Inc. of Hyderabad, India . The application was reviewed under the expedited review provisions of the President s Emergency Plan for AIDS Relief (PEPFAR). However, because patent pro
On February 4, 2008, FDA granted tentative approval for a generic formulation of atazanavir sulfate capsules, 100 mg, 150 mg, and 200 mg, manufactured by Emcure Pharmaceuticals of Pune, India . The application was reviewed under expedited review provisions for the President’s Emer
FDA has approved a new formulation of Epivir (lamivudine) designed to facilitate dosing in appropriate pediatric patients who can reliably swallow tablets. Epivir is now available as 150 mg scored tablets. The scored tablets allow for dosing recommendations in pediatric patients.
The following changes have been made to several sections of the December 1, 2007 version of the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents: What to Start: Initial Combination Regimens for the Antiretroviral-Naive Patient? The Panel revised its recommendations for several p
On January 29, 2008, FDA granted tentative approval for generic lamivudine tablets, 150 mg and 300 mg, manufactured by Hetero Drugs Limited, Hyderabad, India , for use in combination with other antiretrovirals in the treatment of HIV infection. Tentative Approval means that FDA has concluded that a drug product has me
The Food and Drug Administration ( FDA ), on January 18, 2007, granted accelerated approval for etravirine 100 mg tablets, a non-nucleoside reverse transcriptase inhibitor (NNRTI), an antiviral drug that helps to block reverse transcriptase, an enzyme necessary for HIV virus replication. It is the first NNRTI to demons
The Reyataz (atazanavir) package insert was revised to include information regarding the administration of atazanavir and/or atazanavir/ ritonavir with food, proton pump inhibitors, H2 receptor antagonists, acetaminophen, and fluconazole. Additionally, dosing information in patients with renal impairment was included.
This information is designed to support, not replace, the relationship that exists between you and your doctor.