Aranesp mailer catches OPDP's attention

Share this article:
Aranesp mailer catches OPDP's attention
Aranesp mailer catches OPDP's attention

Amgen is the subject of the FDA's latest untitled letters. The regulator's Office of Prescription Drug Promotion (OPDP) knocked the company for a mailer promoting it its chronic kidney disease anemia drug Aranesp.

The marketing watchdog's roster of marketing missteps include what it says is a failure to disclose “material facts from the warnings and precautions section” of the PI. The regulator noted that the drugmaker did include hints like “Visit Aranesp.com for more information,” and “Please see accompanying Aranesp full prescribing information,” in the mailer, but writes that these directions do not make up for this same information not appearing in the mailer itself.

OPDP objections also include a glossing over of patient-dependent dosing, even though the PI includes “extensive instructions that are material for dosing Aranesp, including the starting dose, several different dosing schedules, monitoring requirements, and instructions for subsequent dose adjustments."

Share this article:

Email Newsletters

More in News

Lilly takes on Amgen's Enbrel

Lilly takes on Amgen's Enbrel

Phase-III tests indicate Lilly's experimental treatment bests Amgen's for moderate-to-severe plaque psoriasis.

GSK Ellipta franchise expands

GSK Ellipta franchise expands

The FDA has approved Arnuity Ellipta for asthma.

Five things for pharma marketers to know: Thursday, August 21

Five things for pharma marketers to know: Thursday, ...

An Ebola survivor is set to leave Emory University Hospital, but the cause of the cure is uncertain, the FDA has approved a new type 1 diabetes test, and the ...