Luitpold Pharmaceuticals resumes shipment of Venofer® in North America
On April 26 Galenica acknowledged the voluntary manufacturing and distribution suspension by its US partner Luitpold Pharmaceuticals, Inc. of all products produced at its Shirley, New York, site. Luitpold Pharmaceuticals manufactures Venofer® for the US and Canadian markets at its Shirley facility. The voluntary suspension was implemented in response to an FDA inspection of the site. Venofer® was not the subject of the inspection or of any specific observations of the FDA.
The primary concern for the FDA was the inspection and investigation procedures for particulate matter including glass particles. In March the FDA issued an advisory to drug manufacturers regarding the potential formation of glass fragments in injectable drugs filled in small-volume glass vials called flint glass. Venofer® is packaged in molded glass.
Independent consultants have performed a Product Quality Assessment on Venofer® and confirmed that the product was manufactured in accordance with FDA approval and quality requirements. Luitpold Pharmaceuticals subsequently confirmed that Venofer® meets all USP (United States Pharmacopeia) and internal quality release specifications. The Company received notice from FDA that it did not object to release of lots of Venofer® permitting it to ship products in inventory.
Venofer® is today the most-prescribed intravenous iron in the US with more than 75 million doses (100mg equivalents) sold.
Galenica is a diversified Group active throughout the health care market which, among things, develops, manufactures and markets pharmaceutical products, runs pharmacies, provides logistical and database services and sets up netorks. The Galenica Groups enjoys a leading position in all its business sectors - Pharma, Logistics and Retail. A large part of the Group's income is generated by international operations.
More information is available about the Galenica Group can be found at www.galenica.com