LIVINGSTON, N.J. and PARSIPPANY, N.J. — Columbia Labs has transferred a new drug application for a topical drug designed to prevent premature birth in pregnant women to Watson Pharmaceuticals.
Columbia Labs said Watson now has full rights and regulatory responsibility for all activities and sponsor obligations relating to the application for progesterone vaginal gel 8%. Late last month, the drug received a thumbs-down from an FDA panel that declined to recommend approval for it.
The FDA is expected to take action on the NDA by Feb. 26.
"We continue to enjoy a strong working relationship with Watson, and believe this is the appropriate time to transfer the NDA," Columbia Labs president and CEO Frank Condella said. "As a result of this action, shareholders and other stakeholders can be assured that Watson will provide the resources available, as a result of its position as a $4.6 billion global pharmaceutical industry leader, to support continued progress of this application."