FDA accepts regulatory filing for Prochieve
LIVINGSTON, N.J. — The Food and Drug Administration has accepted a regulatory approval application for a drug designed to prevent premature birth in pregnant women.
Columbia Labs and Watson Pharmaceuticals announced Monday that the FDA would review their application for Prochieve (progesterone gel) for the reduction of risk of preterm birth in women with short uterine cervical length in the third trimester of pregnancy.
“We are pleased to achieve this important regulatory milestone and look forward to working with the FDA as they review the data package for the Prochieve new drug application,” Columbia president and CEO Frank Condella said.
Under a collaborative agreement between Watson and Columbia, Watson will make a $5 million milestone payment to Columbia.