Jane S. Ricciuti, RPh, MS


March 19, 2003

In This Article

Antiretroviral Agents

Zerit XR
Extended-Release (stavudine) Capsules

Manufacturer: Bristol-Myers Squibb Company

Drug Approval Classification: Original New Drug Application (Approval Date: 12/31/02)

New Dosage Form: This new drug application provides for the use of Zerit XR Extended-Release (stavudine) in 37.5-mg, 50-mg, 75-mg, and 100-mg capsules. Zerit XR is a new formulation of stavudine, used for the treatment of HIV-1 infection in adults as part of a combination regimen. In a phase 3 clinical study, the once-daily extended-release formulation of stavudine had similar virologic activity to that of the currently approved immediate-release formulation of Zerit through 24 weeks of combination HIV treatment.

Zerit XR Extended-Release (stavudine) Capsules Letter

Zerit XR Extended-Release (stavudine) Capsules


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