An ongoing dialogue on HIV/AIDS, infectious diseases,
June 20th, 2012
Abacavir Becomes the Latest Generic Antiretroviral Agent
Hot on the heels of generic nevirapine comes generic abacavir:
On June 18, 2012, FDA granted approval for a generic formulation of abacavir tablets, 300 mg, manufactured by Mylan Pharmaceuticals, 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, Ziagen Tablets, a product of VIIV Healthcare Company.
Note that this is for the separate 300 mg tablets, which are approved for twice-daily dosing, and not (yet) for the convenient coformulated once-daily abacavir/3TC tablet.
Nonetheless, it’s notable that a highly effective, well tolerated regimen — abacavir, 3TC, and efavirenz — could now be two-thirds generic, with the last third (efavirenz) probably becoming generic sometime soon.
Does that mean you’ll be switching your patients to generic abacavir once it appears in pharmacies? Let’s do a poll.
Categories: Health Care, HIV, Patient Care, Policy
Tags: 3tc, Abacavir, antiretroviral therapy, generic drugs
You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed.
One Response to “Abacavir Becomes the Latest Generic Antiretroviral Agent”

Paul E. Sax, MD
Associate Editor
NEJM Clinician
Biography | Disclosures & Summaries
Learn more about HIV and ID Observations.
Search this Blog
Follow HIV and ID Observations Posts via Email
Archives
Most Popular Posts
Sorry. No data so far.
-
From the Blog — Most Recent Articles
- Farewell to This Blog — and Hello to NEJM Voices March 2, 2026
- Some Ruminations on CROI — Still the Best HIV Meeting February 26, 2026
- Two Things Can Be True: The FDA Process Was Inconsistent, and the mRNA Vaccine Data Were Disappointing February 17, 2026
- Sometimes You Just Need to Get Input from a Real Human Being February 12, 2026
- Mystifying Abbreviations — Infectious Diseases Edition February 4, 2026
FROM NEJM — Recent Infectious Disease Articles- A Regional Measles Outbreak — South Carolina, 2025–2026 August 13, 2026In South Carolina, 997 measles cases occurred in the reported outbreak. In one health care system, 81 cases were identified. Most were in unvaccinated persons; 13 persons were hospitalized, and 2 had measles encephalitis.
- iEvac-Z, an Inactivated Ebola Vaccine — Phase 1 Study in Japan August 13, 2026Ebola virus continues to be a global threat. In a phase 1 study, an inactivated Ebola virus vaccine was tested in healthy volunteers for safety and immunogenicity.
- Long-Acting Treatment and Advanced HIV Disease — Addressing a Public Health Priority August 13, 2026Without deliberate efforts to evaluate long-acting injectable ART in the populations that need these therapies most, their benefits may accrue primarily to people who are well served by existing systems.
- Disseminated Fusariosis August 13, 2026A 61-year-old man with prolonged neutropenia after chemotherapy for AML was evaluated for persistent fever despite antimicrobial therapy. Physical examination was notable for a skin macule with central necrosis on the chest.
- Clinical Characteristics of Patients Infected with Bundibugyo Virus, DRC 2026 August 6, 2026Bundibugyo virus, a filovirus, is currently spreading in the Democratic Republic of Congo. This report presents early data on symptoms and illness severity as well as diagnostic challenges.
- A Regional Measles Outbreak — South Carolina, 2025–2026 August 13, 2026
-
Tag Cloud
- Abacavir AIDS antibiotics antiretroviral therapy ART atazanavir baseball Brush with Greatness CDC C diff COVID-19 CROI darunavir dolutegravir elvitegravir etravirine FDA HCV hepatitis C HIV HIV cure HIV testing ID fellowship ID Learning Unit Infectious Diseases influenza Link-o-Rama lyme disease medical education MRSA PEP PrEP prevention primary care raltegravir Really Rapid Review resistance Retrovirus Conference rilpivirine sofosbuvir TDF/FTC tenofovir Thanksgiving vaccines zoster

how is abacavir’s mechanism of action?