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Issue No. 22 | May 27, 2011

News and Features

FDA Approves Generic Formulation of Lamivudine and Zidovudine Tablets (150 mg/300 mg) for Marketing in the United States

“On May 25, 2011, FDA granted approval for a generic formulation fixed dose combination of lamivudine and zidovudine tablets, 150 mg/300 mg, a two nucleoside analogue reverse transcriptase inhibitors, indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. …

“FDA has determined that the generic formulation is bioequivalent and, therefore, therapeutically equivalent to the reference listed drug, Combivir Tablets … .

“Approval of this generic formulation means that it may be marketed in the United States.”

More information is available:

FDA Releases Edurant (Rilpivirine) Product Label

On May 20, 2011, the FDA approved rilpivirine (Edurant) for the treatment of HIV in treatment-naive adults. Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that works to block reverse transcriptase, an enzyme necessary for HIV replication. The FDA has posted the product label for rilpivirine (Edurant), which provides information on dosage and administration, contraindications, adverse reactions, drug interactions, pharmacology, and guidance for the use of the medication in specific populations.

More information is available:

CDC Updates "HIV Surveillance in Women" Slide Set

The Centers for Disease Control and Prevention (CDC) recently updated the "HIV Surveillance in Women" slide set with information from the 2009 HIV Surveillance Report. The slide set provides information on HIV infection and AIDS diagnoses in women in the United States and dependent areas, including breakdowns of diagnoses by age group, transmission category, and race/ethnicity.