(BETA) News Briefs: Roche Files for Accelerated Approval of Saquinavir

(BETA) News Briefs: Roche Files for Accelerated Approval of Saquinavir

Bulletin of Experimental Treatments for AIDS, No. 26 September 1995
Ronald Baker, PhD

Roche announced on September 5 that the company submitted to FDA a New Drug Application (NDA) for saquinavir (Invirase) on August 30, 1995. Roche is seeking expedited approval for saquinavir in combination with ddC (Hivid) and/or AZT for the treatment of adults with advanced HIV disease (fewer than 300 CD4 cells/mm3). Roche has also requested approval for saquinavir monotherapy among individuals who have failed or cannot tolerate available treatments.

"Based on research we have conducted, we are confident that Invirase will become a valuable new tool for physicians who treat people with AIDS," said Jurgen Drews, MD, president of Roche international research. See previous article for more on saquinavir and FDA approval.

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