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Mylan Receives FDA Approval For Additional Strength Of Generic Restoril(R)
Mylan Inc. (NASDAQ: MYL) announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (ANDA) for Temazepam Capsules USP, 22.5 mg. This strength is in addition to Mylan"s currently marketed 15 mg and 30 mg strengths of the product.
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Stanford's Kuldev Singh, MD Elected To Chair The Glaucoma Research Foundation
Kuldev Singh, MD, MPH, Professor of Ophthalmology and Director of the Glaucoma Service at the Stanford University School of Medicine, was elected to Chair the Board of the Glaucoma Research Foundation at the Board of Directors Annual Meeting held April 29. The Glaucoma Research Foundation (GRF) is America"s oldest national institution dedicated solely to preventing vision loss from glaucoma.
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CHMP Recommends Expanded Use Of ISENTRESS(R) (Raltegravir), From MSD, In Adult Patients With HIV-1 Infection

Merck Sharp & Dohme Limited (MSD) received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending expanded marketing authorisation for "Isentress" (raltegravir) in combination with other antiretroviral (ARV) medicinal products for the treatment of HIV-1 infection in all appropriate adult patients, including patients starting HIV therapy for the first time (treatment-naç¯ve), as well as treatment-experienced patients. The positive opinion will be reviewed by the European Commission, which grants marketing authorisation to the 27 countries that are members of the European Union (EU), as well as Iceland and Norway. Raltegravir, the first and only approved integrase inhibitor, is currently approved in more than 80 countries across six continents for use in combination with other ARV agents for the treatment of HIV-1 infection in treatment-experienced adult patients with evidence of HIV-1 replication despite ongoing ARV therapy1. If marketing authorisation is granted by the European Commission, the drug will be approved for use both in treatment-naç¯ve and treatment-experienced patients. About Raltegravir Raltegravir works by inhibiting the insertion of HIV-1 DNA into human DNA by the integrase enzyme and has demonstrated rapid antiviral activity2. Inhibiting integrase from performing this essential function limits the ability of the virus to replicate and infect new cells2. There are drugs in use that inhibit two other enzymes critical to the HIV-1 replication process - protease and reverse transcriptase - but raltegravir is the only drug approved that inhibits the integrase enzyme3. Raltegravir is a single 400 mg tablet taken twice daily without regard to food. Raltegravir does not require boosting with ritonavir1. References 1. Summary of Product Characteristics 2. Grinsztejn B, Nguyen BY, Katlama C, et al. Safety and Efficacy of the HIV-1 Integrase Inhibitor Raltegravir (MK-0518) in Treatment-Experienced Patients with Multidrug-Resistant Virus: A Phase II Randomised Controlled Trial. The Lancet 2007; 369:1261-1269. 3. Hazuda DJ, Felock P, Witmer M, et al. Inhibitors of strand transfer that prevent integration and inhibit HIV-1 replication in cells. Science 2000; 287:646-50. Merck Sharp & Dohme Limited


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