Details Basic Details Status Ongoing Last Updated Wednesday, September 2, 2026 Original Posting Date Wednesday, September 2, 2026 Health Outcome(s) cardiac malformations, oral clefts Purpose Drug and Outcome Analysis Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR No Analytic Code Link(s) (1) Cardiac Malformations and Oral Clefts Following in Utero Exposure to Cyclobenzaprine: A Propensity Score Stratified Analysis