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- Minocycline-Induced Hyperpigmentation April 2, 2026A 68-year-old woman with rosacea presented with a 6-week history of dark patches on the skin of her arms and legs. Two weeks before the onset of the skin changes, she had started taking minocycline daily.
- Legislating Medicine — Directed Donation and the Politics of Patient Choice April 1, 2026A Tennessee bill focused on directed blood donation exemplifies a pattern of efforts to legislate medical practice in ways that override scientific consensus while invoking the language of autonomy.
- Probable Japanese Encephalitis Virus Transmission through Organ Transplantation March 26, 2026Infection with Japanese encephalitis virus, a mosquito-borne flavivirus, was identified in a patient who received a liver transplant from a donor who resided in California.
- Communicating about Vaccines in a Politically Contentious Climate March 26, 2026Recent changes in U.S. vaccine policy are sowing confusion and threatening the health of children and the wider population. How should pediatric clinicians communicate with parents to stem the damage?
- Eczema Herpeticum March 26, 2026A 33-year-old pregnant woman with previously controlled atopic dermatitis presented with 3 days of fever and an itchy, painful rash. Erythematous vesiculopapular lesions were noted on the face, neck, chest, and arms.
- Minocycline-Induced Hyperpigmentation April 2, 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?