EpiPen Rival Heads Back To Market After kaléo Retools With ‘100% Automated’ Production
Given US FDA’s strict requirements for generic combination products, brand competitors to Mylan’s pricey epinephrine auto-injector such as kaléo’s Auvi-Q might be the best that buyers can expect for a while.
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Sanofi claims Mylan blocked its competing Auvi-Q product from the market by offering rebates to payers on the condition they would only reimburse for EpiPen; Sanofi seeks treble damages for lost sales.
What began as an overseas recall of one lot made by a Pfizer subsidiary is expanding, threatening to besmirch Mylan’s once golden supply-chain quality record. The recall follows pricing controversy around the EpiPen product got the CEO hauled before Congress.
Pricing controversy around the product got the CEO hauled before Congress; now what began as an overseas recall of one lot made by a Pfizer subsidiary threatens to besmirch Mylan’s once golden supply chain quality record.