FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION THAT CHEWTADZY (TADALAFIL) CHEWABLE TABLETS, 5 MILLIGRAMS, 10 MILLIGRAMS, 20 MILLIGRAMS, WERE NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

WASHINGTON, April 16 -- Food and Drug Administration has issued a notice called: Determination That CHEWTADZY (Tadalafil) Chewable Tablets, 5 Milligrams, 10 Milligrams, 20 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness.

The notice was published in the Federal Register on April 16 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) has determined that CHEWTADZY (tadalafil) chewable tablets, 5 milligrams (mg), 10 mg, 20 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for tadalafil, chewable tablets, 5 ...