FDA Enforcement In Brief
This article was originally published in The Tan Sheet
Perrigo facility undergoes reinspection
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Perrigo stokes momentum behind already healthy sales growth with significant steps in separate areas: a green light for regulatory compliance at its main manufacturing plant, and the launch of its generic OTC versions of Sanofi-Aventis' Allegra.
Continuing remediation at a facility that received an FDA warning letter took a bite out of first-quarter sales for Perrigo, but the private labeler sees continued upside in branded competitor recalls and infant formula growth in the rest of fiscal 2011.
As it announced the formal European Commission approval of its partnered Polpharma Biologics-developed Tyruko natalizumab biosimilar to Tysabri, Sandoz offered Generics Bulletin a timeframe for its expected launch in Europe.