Approval time for CGT designated ANDAs: Review

Till date, USFDA has approved 18 ANDAs with CGT exclusivity.

We have reviewed approval details of 17 out of these 18 ANDAs. Based on that, we have come across the following facts:

·         The average approval time for these 17 ANDAs was approximately 11 months from the date of submission of ANDAs. 5 out of these 17 approved ANDAs had received CRL in the first review cycle. If we remove these 5 outliers from the average then the average approval time for the remaining 12 ANDAs was approximately 9 months.

·         The shortest approval time was 233 days (less than 8 months) while the longest approval time was 626 days (approximately 20 months).

·         More than 75% of these 17 ANDAs were approved by FDA within 12 months of the ANDA submission.

·         The average approval time for topical products was close to 9 months while the average approval time for solid oral products was slightly less than 12 months.

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