GE files sNDA to manufacture Optison

GE Healthcare has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) that would allow the company to manufacture its Optison ultrasound contrast agent at its own manufacturing facility.

Upon approval from the FDA, GE would supply Optison to the U.S. market from its Oslo, Norway, facility and become the only contrast media manufacturer to supply its own stock for the U.S., according to the vendor.

Page 1 of 509
Next Page