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Home » Judge Rules FDA Properly Denied Amgen Six-Month Exclusivity for Sensipar
Judge Rules FDA Properly Denied Amgen Six-Month Exclusivity for Sensipar
A federal judge ruled in favor of the FDA’s decision to deny Amgen market exclusivity for the pediatric dialysis drug Sensipar (cinacalcet), saying the company failed to prove the FDA applied different standards in its review.