Competitive Generic Therapies

On 13 March 2020 the FDA announced the availability of the final guidance for industry.

This guidance provides a description of the process that applicants should follow to request designation of a drug as a competitive generic therapy

(CGT) and the criteria for designating a drug as a CGT. It also includes information on the actions FDA may take to expedite the development and review of abbreviated new drug applications (ANDAs) for drugs designated as CGTs. Finally, it provides information on how FDA implements the statutory provision for a 180-day exclusivity period for certain first approved applicants that submit ANDAs for CGTs.

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