A prior post provided an overview of pediatric exclusivity — how it works and why it was designed this way. This is the first of two posts describing Amgen’s suit against FDA regarding the agency’s denial of pediatric exclusivity for Sensipar (cinacalcet hydrochloride). I’ll start, today, with the back story — the facts and Amgen’s complaint.
Continue reading “Pediatric Exclusivity (2 of 3): Amgen v. Hargan”