Mr. Denis Boucher reports
THERATECHNOLOGIES PROVIDES MANUFACTURING UPDATE ON EGRIFTA(TM)
Theratechnologies Inc. will resume production of EGRIFTA using its original manufacturing process.
Until new lots of EGRIFTA are manufactured using the original process and available for resale, continuing demand for EGRIFTA will be supplied from existing inventory. Based on current sales trend, it is estimated that there is enough supply to meet U.S. market demand until mid-December, 2013, and that the new lots of EGRIFTA will be available for resale prior to this date.
As announced earlier this year, Theratechnologies halted production of EGRIFTA using the original process to rectify issues that were not linked to the product itself but rather related to the consistency of the lyophilization cycle. Corrective measures were developed and implemented and production resumed in May, 2013. Quality issues were recently encountered with the revised manufacturing process. The company decided to carry out further development work on its manufacturing process to optimize it prior to filing documents with the U.S. FDA seeking clearance to resell the new lots of EGRIFTA made with such revised manufacturing process. The manufacturing process to be developed will be submitted to the U.S. FDA prior to its implementation.
The company has informed the U.S. FDA of its decision to resume production using the original process.
We seek Safe Harbor.
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