Preterm birth drug app heads back to FDA

KV Pharmaceutical (NYSE: KV-B) is a step closer to getting its hands on a new drug to prevent preterm births. The company says that Hologic has resubmitted its FDA application for Gestiva, a drug KV paid $70 million for upfront back in January. KV also committed to $120 million in additional payments.

St. Louis, MO-based KV had announced its original intention to license the drug, also known at 17P, more than two years ago. But when the FDA failed to approve it by the beginning of 2009, the two companies went back to the drawing board.

"We believe this latest submission meets all the outstanding FDA requirements and marks an important milestone in the progression toward the potential approval and marketing of this product," says Greg Divis, president of Ther-Rx Corporation, KV's branded subsidiary.

- here's the KV release
- check out the story from the St. Louis Business Journal