On December 20, 2007, FDA granted tentative approval for a generic formulation of efavirenz tablets, 600 mg, manufactured by Emcure Pharmaceuticals of Pune, India The application was reviewed under the expedited review provisions of the President’s Emergency Plan for AIDS Relief (PEPFAR). As with all generic applic
The Lexiva ( fosamprenavir ) label was recently updated to include new drug-drug interaction information regarding phenytoin (an anticonvulsant) and paroxetine (an antidepressent). Details of the newly added information are contained in the attached PDF file. The complete revised label is available at http://ww
The U.S. Food and Drug Administration ( FDA ) issued a final rule on December 18, 2007 requiring manufacturers of over-the-counter (OTC) stand-alone vaginal contraceptive and spermicidal products containing the chemical ingredient nonoxynol 9 (N9) include a warning stating that the chemical N9 does not provide protecti
From the Morbidity and Mortality Weekly Report (MMWR) December 14, 2007 / 56(49);1291-1292 In 1996, the U.S. Public Health Service first recommended using antiretrovirals as postexposure prophylaxis (PEP) after occupational exposure to human immunodeficiency virus (HIV) (1
The Food and Drug Administration ( FDA ) proposes to revise and update the regulations applicable to blood and blood components, including Source Plasma and Source Leukocytes, to add donor requirements that are consistent with current practices in the blood industry, and to more closely align the regulations with curre
On December 1, 2007, 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. The following changes have been made to the October 10, 2006 version of the guidelines. Laboratory Asses
On November 30, 2007, FDA granted tentative approval for a generic version of Tenofovir Disoproxil Fumarate Tablets, 300 mg, manufactured by Matrix Laboratories Limited, of Hyderabad, India . The application was was reviewed under the expedited review provisions of the President s
On November 29, 2007, FDA granted tentative approval for a generic formulation of combination lamivudine/zidovudine tablets, 150 mg/300 mg, manufactured by Matrix Laboratories, Inc. of Hyderabad, India , under expedited review provisions developed for the President s Emergency Plan for AIDS Relief (PEPFAR) Tentati
On November 9, 2007, FDA approved a new half-strength Kaletra tablet formulation. Each film-coated tablet contains 100 mg lopinavir and 25 mg ritonavir . The major changes to the label include clear 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 have undergone a complete revision and reorganization to reflect important new information, and to make
The Food and Drug Administration is publishing final Guidance for Industry on the Role of HIV Resistance Testing in Antiretroviral Drug Development. This final guidance discusses the nonclinical studies (mechanism of action; antiviral activity in vitro; cytotoxicity/therapeutic index; and the effects of serum protein b
On November 2, 2007, the Food and Drug Administration ( FDA ) granted tentative approval for a fixed dose combination of lamivudine/ stavudine (150 mg/40 mg & 150 mg/30 mg combination tablets) under expedited procedures for the President s Emergency Plan for AIDS Relief (PEPFAR) program.
On October 29, 2007, FDA granted tentative approval for a generic formulation of stavudine for oral solution, manufactured by Cipla , Limited, of Mumbai, India . Stavudine is a Nucleoside Reverse Transcriptase Inhibitors (NRTI) indicated for
On October 25, 2007, FDA published draft guidance intended to assist the pharmaceutical industry and other investigators who are conducting new drug development in assessing the potential for a drug to cause severe liver injury (i.e., fatal, or requiring liver transplantation). The document may be of interest to those
On October 12, 2007, the Food and Drug Administration ( FDA ) approved a supplemental new drug application for Lexiva ( fosamprenavir calcium; FPV) Oral Tablets, adding a new indication for once-daily dosing of 1400 mg of Lexiva with 100 mg ritonavir
The Food and Drug Administration ( FDA ) today, October 12, 2007, granted accelerated approval for raltegravir tablets (400 mg) for treatment of Human Immunodeficiency Virus (HIV)-1 infection in combination with other antiretroviral agents. Raltegravir, sold under the trade name Isentress, is the first agent of the pha
On October 4, 2007, FDA granted traditional approval to Aptivus (tipranavir), for combination antiretroviral treatment of HIV-1 infected adults with evidence of viral replication, who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor. Aptivus was granted accelerate
Viracept (nelfinavir mesylate) is a protease inhibitor antiretroviral medicine used in combination with other anti-HIV medications to treat infection with HIV. It is approved for use in adults and in children older than 2 years of age who are infected with human immunodeficiency virus (HIV-1), the virus that causes a
FDA , on August 13, 2007, granted tentative approval for a new fixed dose three-drug combination pill containing generic lamivudine, stavudine and nevirapine , to treat human immunodeficiency virus (HIV-1) infection in children outside the
Abbott has sent out a Dear Healthcare Provider letter highlighting important information about Kaletra dosing for children. A pdf copy of the letter and the accompanying dosing guidelines for children receiving the recommended dose of lopinavir /
FDA , on August 13, 2007, granted tentative approval for a generic formulation of nevirapine tablets, 200 mg, manufactured by Hetero Drugs Limited, Hyderabad, India , under expedited review provisions developed for the President s Emergency Plan for AIDS Relief (PEPFAR).
FDA granted tentative approval on August 8, 2007 for a generic formulation of a combination product, lamuvidine and zidovidine tablets, 150 mg/300 mg, manufactured by Emcure Pharmaceuticals Inc. of Pune, India , under expedited review provisions developed for the President s Emerg
On August 6, 2007, the Food and Drug Administration ( FDA ) approved Selzentry (maraviroc) 150 mg and 300 mg tablets, a CCR5 co-receptor antagonist used in combination with other antiretroviral products for the treatment of adults infected with CCR5-tropic HIV-1. Maraviroc received a priority review by the FDA and is t
FDA approved revised labeling on July 24, 2007 for BARACLUDE (entecavir) 0.5 mg and 1.0 mg Film-Coated Tablets, and BARACLUDE (entecavir) 0.05 mg/mL Oral Solution for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations i
FDA is announcing a meeting of its Antiviral Drugs Advisory Committee on September 5, 2007, scheduled from 8 a.m. to 4 p.m. at the Hilton Washington DC/Silver Spring, The Ballrooms, 8727 Colesville Rd., Silver Spring, MD, 20910. The purpose of the meeting is to discuss new drug application (NDA) 22-145 for the new dr
FDA granted tentative approval on July 12, 2007 for a generic formulation of efavirenz tablets, 600 mg, manufactured by Matrix Laboratories Limited, of Hyderabad, India , under expedited review provisions developed for the President s Emergency Plan for AIDS Relief (PEPFAR). This is a generic formulation of alrea
FDA granted tentative approval on July 10, 2007 for a generic formulation of nevirapine tablets, 200 mg, manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. of Zhejiang China , under expedited review provisions developed for the President s Emergency Plan for AIDS Relief (PE
On June 14, 2007, the Food and Drug Administration approved a new formulation of Lexiva. Lexiva ( fosamprenavir calcium) is now available as an oral suspension (50-mg/mL). The package insert was updated to include information on this new formulation and to provide dosing information for pediatric patients and patients
On May 23, 2007, FDA approved the Procleix Ultrio Assay on the fully automated Procleix TIGRIS system manufactured by Gen-Probe Inc., of San Diego, California, and marketed by Chiron Corporation. This is a fully automated qualitative in vitro nucleic acid test (NAT) to screen for human immunodeficiency virus type 1 (HI
FDA granted approval, on May 23, 2007, to a generic formulation of zidovudine capsules, 100 mg, manufactured by Cipla Limited, of Mumbai, India . The approval means that these generic zidovudine capsules can be marketed in the United States .
A supplement to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents (treatment guidelines) was added on April 30, 2007, discussing use of Entecavir in Hepatitis B/HIV Co-infected patients. Based on preliminary findings from a recent case series of three patients, the Treatment G
FDA granted tentative approval on April 23, 2007 for a generic formulation for stavudine capsules, 30 mg and 40 mg, manufactured by Matrix Laboratories Limited of Hyderabad, India , under expedited review provisions developed for the President s Emergency Plan for AIDS Relief (PEPFAR), http://www.pepfar.
Product labeling for KALETRA ( lopinavir / ritonavir ) has been updated to reflect safety and efficacy data from study M97-720 in treatment-naïve patients out to 360 weeks. Kaletra is manufactured by Ab
Due to water damage caused by flooding over the weekend, FDA has been forced to change the location for the upcoming Antiviral Drugs Advisory Committee meeting on April 24, 2007 to discuss new drug application for maraviroc 300 milligram tablets. Originally scheduled to be held at the FDA, Center for Drug Evaluation an
GlaxoSmithKline recently issued a Dear Pharmacy Professional letter to raise awareness of an isolated, but potentially serious, apparent tampering incident involving Ziagen and Combivir tablets for treatment of HIV.
The Food and Drug Administration, on April 5, 2007, granted tentative approval for abacavir sulfate tablets, 300 mg, manufactured by Matrix Laboratories, Inc., of Hyderabad, India , under expedited review provisions developed for the President s Emergency Plan for AIDS Relief (PEPFAR). This is a generic version of
On March 26, 2007, FDA granted tentative approval for a generic drug formulation of efavirenz tablets (600 mg), manufactured by Strides Acrolab Ltd., Bangalore, India , under the expedited review provisions created by FDA for the President s Emergency Plan for AIDS Relief (PEPFAR)
On March 13, 2007, FDA granted tentative approval for two applications for antiretroviral drugs products made by Strides Acrolab Ltd., Bangalore, India , under the expedited review provisions created by FDA for the President s Emergency Plan for AIDS Relief (PEPFAR). The first is a fixed dose combination of stavudi
On March 8, 2007, FDA granted approval for generic didanosine for oral solution (Pediatric Powder), 10 mg/mL, packaged in 2 gram and 4 gram containers, manufactured by Aurobindo Pharma Limited, of Hyderabad, India , allowing marketing in United States . This is a generic version of the already FD
FDA today issued a public health advisory outlining new safety information, including revised product labeling about erythropoiesis-stimulating agents (ESAs), widely-used drugs for the treatment of anemia in a variety of conditions, anemia due to zidovudine therapy in HIV patients. The drugs affected by the safety u
FDA has issued final guidance, entitled Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), to assist establishments making donor eligibility determinations to comply with the requirements for determining donor-eligibility, including do
FDA and Bristol-Myers Squibb are notifying healthcare professionals of revisions to the MICROBIOLOGY/Antiviral Activity and INDICATIONS AND USAGE/Description of Clinical Studies/Special Populations sections of the prescribing information for Baraclude (entecavir), a nucleoside analog used in the treatment of chronic
Important additions have been made to the Fuzeon ( enfuvirtide ) for injection product label to include a description of nerve bundle pain, hematoma, and cautionary wording regarding Biojector use in patients with coagulopathy. The changes add language to the Precautions, Adverse Reactions, and Dosage and Administratio
The Sustiva ( efavirenz ) package insert has been updated to include drug-drug interaction information regarding coadministration of efavirenz with rifampin, diltiazem, itraconazole, voriconazole, atorvastatin, pravastatin, simvastatin, pimozide and bepridil.
On January 20, 2007, the Food and Drug Administration ( FDA ) granted tentative approval for a new fixed drug combination of lamivudine/ stavudine (150mg/ 30mg or 150mg/40mg) tablets manufactured by Cipla Limited, of Mumbai, India .
This information is designed to support, not replace, the relationship that exists between you and your doctor.