Several years back at a previous company, I dealt with a similar situation where we switched from a round non-scored tablet to a scored bow-tie shaped tablet.
1) I believe it is OK that both tablets are on the market at same time but you should only be distributing the new tablet while the old tablet depletes. I don't think you should be shipping both old and new at same time.
2) I don't believe there is a need to wait for the old tablet to deplete before launching the new tablet. We communicated a date on which the old tablet would be stopped and the next day the new tablet would start distribution. I would think if you delay the new tablet launch to let old tablet deplete you may risk a stock out. Also, we had to add a banner to the labels stating "new scored tablet". This had to be used for 6 months. But this was all dealt with within the supplement for the new scored tablet.
3) I don't think there is any deadline for the switchover - just when you stop distributing the old tablet you should be ready to start the new tablet the next day (or shortly thereafter).
4) I didn't handle SPL submissions but I recall there is a field for marketing start and end dates which we filled out for the end of the old tablet and start of the new. The new labeling for the new tablet was submitted so it got posted to DailyMed right away even though the old tablet was still in the distribution chain being depleted.
Hope this helps.
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Tom
Senior Director, Regulatory Affairs CMC
Chicago
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Original Message:
Sent: 17-Jul-2019 11:38
From: David Lucking
Subject: Life Cycle Management
Dear Colleagues,
I have questions concerning life cycle management (LCM).
1. When converting from a round tablet to a capsule shaped tablet can both presentations be on the market at the same time? (There will be differences in labeling necessitated by the change in shape).
2. Can the launch of the tablet shaped tablet be delayed while inventory of the round tablet is depleted?
3. Is there any mandatory time period for making the switch over?
4. What is the effect of having to submit the content of labeling in SPL format to the FDA's eLIST system, so that the revised labeling is accessible on publicly available labeling repositories? (especially if the launch of the capsule shaped product is delayed)
Thank you for your input!
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David Lucking
FL
United States
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