13 March 2020 - Today, the U.S. FDA finalised guidance for industry, “Competitive Generic Therapies” (CGTs), which describes the process that generic drug applicants should follow to request designation of a drug as a CGT and the criteria for that designation.

The final guidance provides information on actions the FDA may take to expedite development and review of Abbreviated New Drug Applications (ANDAs) for drugs designated as CGTs and explains how the FDA implements the statutory provisions providing for a 180-day exclusivity period for certain first-approved applicants who submit ANDAs for CGTs.

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