FDA Awards Pfizer Approval, Priority Review for 2 Drugs

The FDA has given the green light to Pfizer’s QuilliChew ER chewable tablets for the treatment of Attention Deficit Hyperactivity Disorder in patients 6 and older.

The central nervous system stimulants demonstrated superiority over placebo in a 90-patient laboratory classroom study of children ages 6 to 12 with an ADHD diagnosis. QuilliChew ER is planned to be launched in pharmacies in the first quarter of 2016.

Pfizer also won priority review from the FDA for its Xalkori (crizotinib) sNDA for the treatment of metastatic non-small cell lung cancer in patients whose tumors are ROS1-positive. The projected FDA action date is April 2016.

The treatment received breakthrough therapy designation for this indication in April, and is currently indicated for patients with metastatic NSCLC whose tumors are anaplastic lymphoma kinase-positive.