FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION THAT ACTIGALL (URSODIOL) CAPSULE, 150 MILLIGRAMS, WAS NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

WASHINGTON, May 30 -- Food and Drug Administration has issued a notice called: Determination That ACTIGALL (Ursodiol) Capsule, 150 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness.

The notice was published in the Federal Register on May 30 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) has determined that ACTIGALL (ursodiol) capsule, 150 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ursodiol capsule, 150 mg, if all other legal and regulatory requirements are met.

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