In the submission, Columbia Laboratories has requested Priority Review to the FDA.
The NDA submission includes data from two Phase III clinical trials evaluating the use of Prochieve in reducing the risk of preterm birth in women, as well as supportive pharmacokinetic studies.
Columbia Laboratories president and CEO Frank Condella said the recently published PREGNANT study has demonstrated that the use of Prochieve can reduce the incidence of early preterm birth in women with a short cervix at mid-pregnancy and the study also provided evidence of improvement in infant outcome.
"We now await notice from the FDA on whether our NDA submission has been accepted for filing, as well as a decision on our request for Priority Review which, if granted, could result in an action letter from the FDA in the fourth quarter of this year," Condella said.
Watson Global Brands EVP Fred Wilkinson said the combination of cervical screening, together with Prochieve therapy, if approved by the FDA, may result in significant clinical benefits in a population where there are currently no effective therapies
"We are committed to working closely with Columbia and FDA during the review of the data submitted within the NDA, which we believe will ultimately support approval of this potential therapy," Wilkinson said.
In March 2010, Watson has entered into an agreement to expand their Women’s Health brand product portfolio with the acquisition of the exclusive US rights to Columbia Laboratories’ bioadhesive progesterone gel products Crinone and Prochieve for the indications of infertility and secondary amenorrhea.