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Elan Corporation, plc Message Board

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  • dar200 dar200 Feb 10, 2005 3:10 PM Flag

    Manufacturing

    Within the last two weeks or so, a few posters who say they are MS patients reported 11/05 expiration dates on their vials. Product manufactured in 08/04 carries a 11/05 expiration date. Then a poster who says he is a patient said he saw a vial with a 12/05 expiration on 1/31/05.

    Assuming the posted information is correct it means to me that no later than 1/31/05 ELN and BIIB (not wholesalers and distributors) had no more 08/04 production in stock.

    Now I'm waiting for an end user (patient or MD) to report the date an expiration date of 01/06 is first seen. If first-hand people report the dates, we can calculate how fast ELN/BIIB is running thru monthly production.

    I share your concern about production capacity.
    By tracking how fast elb/biib is running through each months production, this board can lead the market in seeing a capacity limit approaching (if it approaches).

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    • Dar, at least one person had a vial that had been repackaged. My guess is that it may have had a 'for experamental use only' label on it and was re-labeled. Also, the drug is not always manufactured and filled & finished in the same facility, so the date may be less important than the batch number. I think some may have been in 'bulk' containers before approval, filled and labeled 11/05 exp, after FDA approval. I am guessing, but it seems to fit the circumstances.
      Regards,
      AZ

      • 1 Reply to AZErnie
      • I know nothing about any repackaged vial. The FDA approval letter on dating is pretty clear to me even though the definition of the date of manufacture is redacted. I doubt the date is filling date.

        Even if it is, an expiration month is an expiration month. When the expiration month changes to the next month at the end user level, that means eln/biib is out of the prior month's production (assuming you accept the proposition that the oldest inventory is shipped first).

 

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