WASHINGTON — Molecular Biosystems Inc. and Mallinckrodt Inc. said they won U.S. approval to sell the first of a new generation of imaging agents used with ultrasound procedures.
The Food and Drug Administration approval for the product, called Optison, is key for San Diego-based Molecular Bio, which has been part of a legal struggle with Sonus Pharmaceuticals Inc. and other drug companies over how the FDA regulates imaging agents.
Though Molecular Bio was originally the leader in the race to get one of the new-generation agents to market, its lead was endangered by the legal battle and a subsequent FDA ruling that required the company to meet more requirements for approval. Molecular Bio developed the agent, a drug injected into the body to help doctors obtain a clearer picture of the heart during ultrasound procedures.
"It's a seminal event for the company," said Peter Drake, an analyst with Vector Securities. "I see this as a major vindication for the company and for the product."