FDA's qualifications on GUSTO

WASHINGTON - The FDA approved the accelerated infusion regimen of Genentech Inc.'s Activase tPA. Physicians now may administer the drug over a 90-minute regimen rather than the three hours under the previously approved label.

The revised label incorporates data from the 41,000-patient GUSTO-I study, which compared accelerated administration of Activase with two regimens using streptokinase and a fourth regimen that combined Activase and a lower dose of streptokinase...