Gliatech
This article was originally published in The Gray Sheet
Executive Summary
Relaunch of Adcon-L outside the U.S. is slated for June 2001, assuming completion of manufacturing validation runs, company announces April 18. Gliatech has received a recommendation for ISO 9001 recertification following a successful European audit. The company recalled its Adcon-T/N and Adcon-L gel lines in January due to a supplier recall (1"The Gray Sheet" Jan. 15, 2001, p. 23). U.S. relaunch of Adcon-L is contingent on "submission and approval of the additional data identified as part of the FDA's Application Integrity Policy status," the release notes
You may also be interested in...
Gliatech Halts Distribution Of Sole U.S. Product Following Supplier Recall
Clinical trials in support of premarket approval applications for Gliatech's Adcon-A and Adcon-P anti-adhesion solutions will go unaffected by the firm's decision to temporarily discontinue distribution of Adcon-L gel on account of a supplier recall. The recall also affects another gel formulation, Adcon-T/N.
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
P&G Restores Volume Growth In Beauty, Grooming After Pricing Run
Procter & Gamble reports strong consumer spending in the US and Europe after a 3% increase in product pricing over the past year. Dragging on fiscal third-quarter results, sales of SK-II in China fell 30% for the January-March period, while lower incidence of cough and cold impacted Health Care performance.