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FDA asks Baxter to stop distributing Aralast NP brochure to physicians
The US Food and Drug Administration has warned Baxter International Inc. against including what the agency called “misleading statements” in a physicians’ brochure for Aralast NP, an augmentation therapy for Alpha-1 Antitrypsin Deficiency.
The agency asked Baxter to stop distributing the material. In a statement Tuesday, Baxter said it put the material on hold, submitted a response to the FDA on Aug. 10 and “takes the agency’s concerns seriously.”
The FDA letter notes that Baxter has been warned for similar violations twice before in the past two years.
