On December 30, 2008, FDA approved the first nucleic acid test (NAT) that screens for the presence of two divergent types of HIV in donated blood plasma and human tissue. Nucleic acid is the term commonly used to refer to the chemical compounds that make up the genetic material in the virus. The new FDA-approved test d
On December 29, 2008 FDA granted approval for three generic fomulations of stavudine. Stavudine is a Nucleoside Reverse Transcriptase Inhibitors (NRTI), which helps keep HIV, the virus that causes AIDS, from reproducing. It is intended to be used in combination with other anti-retroviral agents for the treatment of HIV
On December 23, 2008, FDA granted tentative approval for a generic version of emtricitabine capsules 200 mg, manufactured by Matrix Laboratories, Ltd., of Hyderabad, India , reviewed under the expedited review provisions for the President’s Emergency Plan for AIDS Relief (PEPFAR). Emtricitabine is a Nuceloside Reverse
On December 19, 2008 FDA approved Ziagen ( abacavir ) 300 mg scored tablets with corresponding dosing information for pediatric patients weighing 14 kg or more using the scored tablet. The Dosage and Administration and the Clinical Pharmacology sections were
On December 19, 2008, FDA granted tentative approval for fixed-dose combination scored tablets, made by Aurobindo Pharma Limited of Hyberdad, India , containing abacavir sulfate and lamivudine, 60mg/30mg, indicated in combination with other antiretrovirals for the treatment of HIV-1 infection, . The tablets are dispers
On December 18, 2008 FDA approved new pediatric dosing recommendations for a new 75 mg Prezista (darunavir) tablet formulation for patients from 6 to less than 18 years of age. Section 1 Indications and Usage, Section 2 Dosage and Administration, and Section 3 Dosage Forms and Strenghts were modified to reflect the cha
On December 12, 2008, FDA granted tentative approval for efavirenz 100 mg scored tablets, indicated in combination with other antiretrovirals for the treatment of HIV-1 infection, facilitating pediatric treatment. The product is manufactured by Aurobindo Pharma Limited, Hyberdad, India
On Dec 11, 2008, FDA s Obstetrics and Gynecology Devices Panel will meet from 8:00 AM - 5:30 PM at the Gaithersburg Holiday Inn, Walker/Whetstone Salons Two Montgomery Village Ave.,in Gaithersburg, MD. (301.948.8900) The committee will discuss, make recommendations, and vote on a premarket approval application for the
On November 25, 2008, FDA granted full, traditional approval for the use of maraviroc in treatment-experienced patients infected with CCR5-tropic HIV-1. The change from accelerated to traditional approval was based on 48 week data from two double-blind, randomized, placebo-controlled,multicenter studies in subjects inf
The Food and Drug Administration ( FDA ) published a final rule on November 10, 2008 amending the classification regulation for male condoms made of natural rubber latex (latex condoms) and latex condoms with spermicidal lubricant containing nonoxynol-9 (N-9), designating a guidance document containing labeling recomme
On November 3, 2008, the DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents released a revised version of the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents.
This message describes the following important changes affecting Prezista (darunavir) Traditional approval of Prezista New dosing regimen for treatment-naïve patients New 400 mg tablets Revised Pregnancy Category On October 21, 2008, FDA granted traditional approval to Prezista (darunavir) 600 mg, co-administered with
On October 7, 2008, FDA granted tentative approval for a generic formulation of lamivudine 150 mg and 300 mg tablets, manufactured by Macleods Pharmaceuticals Limited of Daman, India , indicated for use in combination with other anti-retroviral drugs for the treatment of HIV-1 infection. They come packaged as follo
On September 30, 2008, FDA approved an alternative dosing regimen for Reyataz ( atazanavir ) for HIV-1 infected treatment-naive patients who can take ritonavir . The recommended dosage is Reyataz 300 mg with ritonavir 100 mg once daily for treatment-naive patient
On September 29, 2008, FDA approved a pediatric efficacy supplement for Videx EC (didanosine) Delayed-Release Capsules, expanding the indication to include children weighing at least 20 kg The main changes include revisions to the Dosage and Administration section as follows: The recommended total daily dose to be ad
On September 24, 2008, FDA approved a generic formulation of Didanosine (ddI) Delayed Release Capsules, 125 mg, 200 mg, 250 mg, and 400 mg, manufactured by Aurobindo Pharma Limited, Hyberdad, India . Didanosine is a Nucleoside Reverse Transcriptase Inhibitors (NRTI), which helps keep HIV, the virus that causes AIDS, fr
On September 19, 2008, FDA approved a pediatric efficacy supplement for Retrovir syrup, capsules and tablets allowing for a twice daily dosing regimen in children 6 weeks to 18 years of age. It also provides for dosing by weight in addition to dosing by body surface area. Previously, Retrovir dosing recommendations for
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The Food and Drug Administration ( FDA ) today issued two Warning Letters to Ranbaxy Laboratories Ltd., of the Republic of India , and an Import Alert for generic drugs produced by Ranbaxy s Dewas and Paonta Sahib plants in India. The Warning Letters identify the agency s concerns about deviations from U.
On September 12, 2008, FDA granted tentative approval for abacavir sulfate 60 mg scored tablet for use in pediatric patients. Abacavir sulfate 60 mg scored tablets are manufactured by Aurobindo Pharma Limited, Hyberdad, India . Abacavir sulfate is an antiviral agent in the Nucleoside Re
On September 3, 2008, FDA granted tentative approval for the first generic combination formulation of abacavir sulfate and lamivudine tablets, 600 mg/300 mg, manufactured by Aurobindo Pharma Limited, Hyberdad, India . Abacavir sulfate and lamivudine are antivral agents in the Nucleoside
FDA approved, on August 29, 2008, changes to the product label for Norvir (ritonavir) Soft Gelatin Capsules, and Norvir Oral Solution reflecting new, post marketing information regarding QT/QTc interval and PR interval prolongation information from Study M06-80. The patient package insert has been updated, as wel
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. In addition, information regarding oral and pa
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 treatmen
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 40mg/150mg/
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, Hyberdad,
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 Emergency
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.