FDA Cuts Wait for Certain ANDA Approvals, Clears Up Misunderstandings on Reference Drugs

To help speed the approval of generics, the FDA said it would not wait for the Federal Register to publish determinations that a reference listed drug’s removal from sale had nothing to do with safety and effectiveness.

Previously, the FDA would publish its findings that a drug was removed from the market for reasons other than its safety and effectiveness before it approved any related ANDAs.

Sponsors must prove that their proposed generics are the same as the reference listed drugs with respect to the active ingredients, dosage forms, route of administration, strength, labeling, and conditions of use, among other characteristics, the draft guidance explained.

Order your copy of Achieving ANDA Success: Working with the FDA to Win First-Cycle Approval today — applicants who get it right the first time can get their products to market quicker.