FDA’s Tablet Scoring Final Guidance Requires Generics To Be Same As Brand

Generic industry concerns that scoring conventions could create barriers to entry did not win out in final tablet scoring guidance; FDA says to contact it if the scoring convention is patent protected.

FDA has not changed requirements that tablet scoring for generics should be identical to their reference products in its final guidance, despite industry concerns that it could be used by brands to prevent competition.

FDA has said it has enforcement discretion to deal with patent issues if they arise, but the agency chose to...