Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Genzyme Receives "Complete Response," Warning Letters For Lumizyme

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The hits just keep on coming for Genzyme. On a March 2 call with investors, the firm had to announce not just a "complete response" letter for its 2000-liter scale-up of Myozyme (which will be called Lumizyme for the larger production scale), but also that its Allston Landing manufacturing site had received a 483 report from FDA and a subsequent warning letter

You may also be interested in...

Rationing Of Genzyme’s Myozyme In Europe Likely Through April Due To Supply Constraints

Until approval of the larger 4000 L bioreactor for the Pompe Disease product, EMEA recommends priority access for infants, children and adolescents.

FDA Agrees To Accelerated Approval For Myozyme Scale-Up, Genzyme Says

The 2,000L version of Myozyme on track for approval with a post-market confirmatory trial in February; user fee date extended while FDA reviews REMS submission.

Pending Approvals Hold Major Implications For Myozyme Growth

Genzyme reports increasing sales for Pompe disease drug, but upcoming EU and FDA decisions could spur or stifle product’s growth.

Related Content





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts