Belcher Pharmaceuticals, LLC.: Ablysinol

1. Because the effect of Ablysinol is usually manifest rapidly, we feel confident that it is effective, despite the absence of the usual level of trial evidence.

We acknowledge receipt of your proposal dated November 2, 2015, containing your proposed postmarketing study design to address these issues.

2. From the chemistry, manufacturing and controls (CMC) perspective, NDA 207987 cannot be recommended for approval because of unresolved CMC deficiencies, resulting in the 'withhold' recommendation issued by the Office of Process and Facility for the drug substance manufacturing facility.

A. Drug Product Specification: You need to provide CMC information concerning the validated analytical methods to be included in the revised drug product specification.

D. Labeling: You need to revise the carton and container labels using the approved trade name.

Section 505(0)(3) of the FDCA authorizes FDA to require holders of approved drug and biological product applications to conduct postmarketing studies and clinical trials for certain purposes, if FDA makes certain findings required by the statute.

The use of Ablysinol during percutaneous transluminal septal myocardial ablation (PTSMA) may cause heart block, cardiac arrhythmias, myocardial infarction, and coronary artery dissection.

Based on the above, FDA has determined that if NDA 207987 is approved, an analysis of spontaneous postmarketing adverse events reported under subsection 505(k)(1) of the FDCA will not be sufficient to assess a known serious risk of peri- and post-procedural adverse events following PTSMA with Ablysinol.

Therefore, based on appropriate scientific data, FDA has determined that, if NDA 207987 is approved, you will be required to conduct the following:

Any additional specific details of this required postmarketing study, including a timetable and annual reporting requirements, will be described more fully in the approval letter for this application, if it is approved.