Tablet and capsule interchangeability as solid oral dosage forms urged by Perrigo.
This article was originally published in The Tan Sheet
Executive Summary
TABLET, CAPSULE INTERCHANGEABILITY AS SOLID ORAL DOSAGE FORM URGED by private label manufacturer Perrigo. The firm also suggests that FDA consider tablets and capsules as the same (i.e., solid oral) dosage forms as caplets, "Penta"-shaped tablets (i.e., J&J/Merck's Pepcid AC) or other shaped tablets, the company maintains in June 26 comments to the agency. The company was responding to an FDA request for comments on whether there should be any change in agency policy to limit permitting bioequivalent tablets and capsules to be listed as "therapeutically equivalent" in the "Orange Book" or should FDA regard tablets and capsules as the same (solid, oral).