Mallinckrodt files NDA for Optimark

Mallinckrodt has filed a new drug application for its Optimark MRI contrast agent, the St. Louis company announced this month. Optimark (Gd-DTPA-BMEA) is an extracellular agent designed for visualizing lesions in the brain, spine, and liver. Mallinckrodt developed the product internally.

Optimark's approval will be an important milestone for Mallinckrodt, rounding out its product portfolio and making it easier for the company to win single-source supply deals with large purchasers. Mallinckrodt's product line already includes agents for x-ray, ultrasound, and CT, as well as organ-specific MRI studies, but the firm does not offer contrast media for MRI scans in the central nervous system, which composes the lion's share of MRI studies. Optimark will compete with general-purpose MRI agents such as Schering's Magnevist, Bracco's ProHance, and Nycomed Amersham's Omniscan.