FDA Notifications
FDA approves generic AZT
The Food and Drug Administration (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. Tablet and oral solution dosage forms of generic zidovudine were previously approved for sale in the United States as the patents on those dosage forms expired in September 2005. An earlier generic version of the capsule formulation was approved for marketing in the United States in 2006, following the expiration of GlaxoSmith-Kline's patent on its Retrovir brand capsule.
A list of FDA approved generic antiretroviral drugs for the treatment of HIV is available on the web at http://www.fda.gov/oashi/aids/viralsgeneric.html.
Zidovudine is in the class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs), which help keep the AIDS virus from reproducing. This anti-retroviral drug is intended to be used with other anti-retroviral agents for the treatment of HIV-1 infection.
The approval of generic zidovudine means that there are no existing patents and/or exclusivity preventing the approval of generic versions of this product to prevent marketing in the United States.
As with all FDA-approved generics, this product must meet all of FDA's manufacturing quality and clinical safety and effectiveness standards for U.S. marketing.
FDA approves NAT for HIV screening
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 (HIV-1) and hepatitis C virus (HCV) RNA in donated blood from donors of whole blood, blood components, or source plasma. It is also licensed to screen individual organ donations from living donors, heart-beating organ donors, and cadaveric (non-heart-beating) organ donors. The capability of full automation will reduce human error and accelerate blood screening, enhancing blood safety.
On May 11, 2007, FDA granted marketing approval to two HIV-1 PCR assays for use in managing the treatment HIV infection.
The Abbott RealTime HIV-1 Assay, made by ABBOTT Molecular, Inc., is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for the quantitation of Human Immuno-deficiency Virus type 1 (HIV-1) on the automated m2000 System in human plasma from HIV-1 infected individuals over the range of 40 to 10,000,000 copies/mL. The Abbott RealTime HIV-1 assay is intended for use in conjunction with clinical presentation and other laboratory markers for disease prognosis and for use as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels. (Product label).
The COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, made by Roche Diagnostics is an automated PCR test, indicated for the quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) nucleic acid in human plasma (viral load) for use in conjunction with clinical presentation and other laboratory markers. The test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients. It can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy by measuring changes in plasma HIV-1 RNA levels during the course of antiretroviral treatment.
The Food and Drug Administration (FDA) granted approval, on May 23, 2007, to a generic formulation of zidovudine capsules, 100 mg, manufactured by Cipla Limited, of Mumbai, India.Subscribe Now for Access
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