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Penwest drops "not approvable" beta blocker

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Penwest halts efforts to develop beta blocker PW2101 for hypertension and angina following receipt of a "not approvable" letter from FDA, announced June 29. The firm filed the NDA Aug. 30 under the 505(b)(2) approval pathway, setting a user fee deadline of June 30. FDA issued the letter due to "the degree of kinetic variability of PW2101 observed among individuals and because beta blockade as a surrogate for efficacy was not demonstrated across the entire inter-dosing interval on an individual subject basis," Penwest said. PW2101 uses Penwest's TIMERx oral controlled-release delivery system...
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